Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw

{0} FDA U.S. FOOD & DRUG ADMINISTRATION August 6, 2026 Nobel Biocare AB Bernice Jim Head of RA Implant Systems Vastra Hamngatan 1 Goteborg, Vastra SE 411 17 SWEDEN Re: K253999 Trade/Device Name: Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw; Healing Abutment Conical Connection Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: July 6, 2026 Received: July 6, 2026 Dear Bernice Jim: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K253999 - Bernice Jim Page 2 If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. {2} K253999 - Bernice Jim Page 3 For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, ANDREW I. STEEN -S Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} # Indications for Use Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. K253999 Please provide the device trade name(s). Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw Please provide your Indications for Use below. Universal Bases ASC Engaging: Universal Bases ASC Engaging are indicated to support the placement of single unit, screw retained prosthetic restorations in the maxilla or mandible. The Universal Base consists of two major parts. Specifically, the titanium base and mesostructured components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from intra oral scanners, CAD software, CAM software, ceramic and ceramic-dominant material, milling machine and associated tooling and accessories. Universal Bases ASC Non-Engaging: Universal Bases ASC Non-Engaging are indicated to support the placement of multiple unit, screw retained prosthetic restorations in the maxilla or mandible. The Universal Base Non-Engaging consists of multiple parts. Specifically, the titanium base and multi-unit mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from intra oral scanners, CAD software, CAM software, ceramic and ceramic-dominant material, milling machine and associated tooling and accessories. Universal Bases MUA ASC: Universal Base MUA ASC are indicated to support the placement of multiple unit, screw retained prosthetic restorations in the maxilla or mandible. The Universal Base MUA consists of three major parts, specifically the Multi-unit abutment, the Universal Base MUA and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from intra oral scanners, CAD software, CAM software, ceramic and ceramic-dominant material, milling machine and associated tooling and accessories. Temporary Abutment Engaging and Non-Engaging: Temporary Abutments Engaging CC are indicated for use with single unit screw- retained temporary dental prostheses placed on endosseous dental implants in the maxilla and mandible, for up to 180 days. Temporary Abutment Non-Engaging CC are indicated for use with multiple unit screw-retained temporary dental prosthesis placed on endosseous dental implant in the maxilla and mandible, for up to 180 days, for implants with less than 14° overall divergences to allow path of insertion. Omnigrip Clinical Screw Titanium: Clinical Screws are indicated for use to secure a dental abutment or framework to a dental implant in the {4} maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation. Omnigrip Prosthetic Screw: Prosthetic screws are indicated for use to secure a dental abutment or framework to a dental abutment or base in the maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation. Healing Abutment Conical Connection: The Healing Abutments Conical Connection are premanufactured prosthetic components to be directly connected to the endosseous dental implants or abutments and are indicated as temporary components for one single tooth to full arch denture procedures. Please select the types of uses (select one or both, as applicable). ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) {5} K253999 Nobel Biocare™ # 1 – 510(k) Summary # 1.1 Submitter Information Submitter: Nobel Biocare AB Vastra Hamngatan 1 Goteborg 411 17 Sweden Submitted By: Nobel Biocare Services AG Balz-Zimmerman-Strasse 7 8302 Kloten Switzerland Contact Person: Bernice Jim, PhD E-Mail: regulatory.affairs.nb@envistaco.com Telephone Number: +41 43 211 42 00 Prepared By: Nicole Fuchs, MLaw Oversight (Manager): Valeria Barbarito, MSc Date Prepared August 6th 2026 # 1.2 Device Name No. 1 Proprietary name: Universal Base ASC Engaging Manufacturer: Nobel Biocare AB Common Name: Dental Abutment Classification Name: Endosseous Dental Implant Abutment Regulation Number: 21 CFR 872.3630 Device Class: II Primary Product Code: NHA Secondary Product Code: PNP {6} Nobel Biocare™ ### 1.3 Device Name No. 2 Proprietary name: Universal Base ASC Non-Engaging Manufacturer: Nobel Biocare AB Common Name: Dental Abutment Classification Name: Endosseous Dental Implant Abutment Regulation Number: 21 CFR 872.3630 Device Class: II Primary Product Code: NHA Secondary Product Code: PNP ### 1.4 Device Name No. 3 Proprietary name: Universal Base MUA ASC Manufacturer: Nobel Biocare AB Common Name: Dental Abutment Classification Name: Endosseous Dental Implant Abutment Regulation Number: 21 CFR 872.3630 Device Class: II Primary Product Code: NHA Secondary Product Code: PNP ### 1.5 Device Name No. 4 Proprietary name: Temporary Abutment Engaging and Non-Engaging Manufacturer: Nobel Biocare AB Common Name: Dental Abutment Classification Name: Endosseous Dental Implant Abutment Regulation Number: 21 CFR 872.3630 Device Class: II Product Code: NHA {7} Nobel Biocare™ ### 1.6 Device Name No. 5 | Proprietary name: | Healing Abutment Conical Connection | | --- | --- | | Manufacturer: | Nobel Biocare AB | | Common Name: | Dental Abutment | | Classification Name: | Endosseous Dental Implant Abutment | | Regulation Number: | 21 CFR 872.3630 | | Device Class: | II | | Product Code: | NHA | ### 1.7 Device Name No. 6 | Proprietary name: | Omnigrip Clinical Screw Titanium | | --- | --- | | Manufacturer: | Nobel Biocare AB | | Common Name: | Dental Abutment Screw | | Classification Name: | Endosseous Dental Implant Abutment | | Regulation Number: | 21 CFR 872.3630 | | Device Class: | II | | Product Code: | NHA | ### 1.8 Device Name No. 7 | Proprietary name: | Omnigrip Prosthetic Screw | | --- | --- | | Manufacturer: | Nobel Biocare AB | | Common Name: | Dental Abutment Screw | | Classification Name: | Endosseous Dental Implant Abutment | | Regulation Number: | 21 CFR 872.3630 | | Device Class: | II | | Product Code: | NHA | ### 1.9 Predicate Device **Primary Predicate** K200040 Universal Base Conical Connection, Nobel Biocare {8} N Nobel Biocare™ # Reference Devices | 1 | K233208 | NobelProcera Titanium Abutment ASC, Nobel Biocare | | --- | --- | --- | | 2 | K240982 | DESS® Dental Smart Solutions, Terrats Medical SL | | 3 | K211109 | N1 Base Xeal + Universal Abutment N1 Base Tri Bridge, Nobel Biocare | | 4 | K201860 | Elos Accurate Hybrid Base (Universal Base non-engaging Elos), Elos | | 5 | K211109 | Temporary Abutment Nobel Biocare N1™ TCC, Nobel Biocare | | 6 | K161435 | Temporary Snap Abutment (Engaging and Non-Engaging), Nobel Biocare | | 7 | K102436, K133731 | Healing Abutment Conical Connection, Nobel Biocare | | 8 | K233208 | Omnigrip Clinical Screw Titanium, Nobel Biocare | | 9 | K211109 | Clinical Screw Multi-unit Abut Nobel Biocare N1 TCC, Nobel Biocare | | 10 | K220048 | Prosthetic Screw NobelProcera Zr Nobel Biocare N1 Base, Nobel Biocare | | 11 | K202452 | Prosthetic Screw MUA Omnigrip Mini, Nobel Biocare | ### 1.10 Device Description Summary The subject device Universal Base ASC is composed of three device lines: - Universal Base ASC (including three devices: Universal Base ASC Engaging, Universal Base ASC Non-Engaging, Universal Base MUA ASC) - Temporary Abutments (including two devices: Temporary Abutments Engaging and Non-Engaging, Healing Abutment Conical Connection) - Screws (including two devices: Omnigrip Clinical Screw Titanium and Omnigrip Prosthetic Screw). Universal Base ASC and Temporary Abutment device lines are premanufactured dental implant abutments which can either be connected directly to a Nobel Biocare Conical Connection implant or to a Multi-unit Abutment to support the placement of a screw-retained dental prosthesis. The Universal Base ASC device line integrates a digital workflow using a dental CAD software and is milled from zirconia. Both Universal Base ASC and Temporary Abutment device lines are available in the platform sizes NP, RP and WP and are intended for use as an aid in prosthetic rehabilitation to restore chewing function and esthetic appearance. {9} Nobel Biocare™ The Universal Base ASC and Temporary Abutments device lines are connected to the implant with a clinical screw. The Universal Base ASC features an angulated screw channel which can be defined by the end user in an angulation (to the implant's axis) between 0° and 25°. The clinical screw features the Omnigrip Interface which allows tightening up to 25°. The Universal Base ASC, Temporary Abutments and Screw device lines are composed of titanium vanadium alloy Ti6Al4V ELI (ISO 5832-3, ASTM F136), the surface of the abutments is provided with full anodization and the Clinical Screws are provided with, without and with partial DLC coating. ### 1.10.1 Device Description Summary The tables below outline the material compositions and relevant size ranges (e.g. diameter, length, angulation, etc.) for all models of each device component for the proposed Universal Base ASC Engaging, Universal Base ASC Non-Engaging, Universal Base MUA ASC, Temporary Abutments Engaging and Non-Engaging, Healing Abutments Conical Connection, Omnigrip Screw Clinical Titanium, and Omnigrip Prosthetic Screw devices. ### Design specifications Universal Base ASC Engaging and Non-Engaging: | Parameter | Specification | | --- | --- | | Maximum Mesostructure Angulation | 20° | | Maximum Angulation of screw channel | 25° | | Min Wall Thickness | 0.5 mm | | Max Wall Thickness | Based on the blank dimensions available for Vita YZ® ST Multicolor by Vita | | Min Abutment Post Height | 4 mm | | Max Abutment Post Height | Based on the blank dimensions available for Vita YZ® ST Multicolor by Vita | | Min Gingiva Height | 1 mm (given by the standardized abutment shape of the Universal Base Engaging and Non-Engaging) | | Max Gingiva Height | 3.5 mm (given by the standardized abutment shape of the Universal Base Engaging and Non-Engaging) | | Compatible cement | Multilink Hybrid by Ivoclar Vivadent (K130436) | {10} N Nobel Biocare™ Universal Base ASC MUA: | Parameter | Specification | | --- | --- | | Maximum Mesostructure Angulation | 20° | | Maximum Angulation of screw channel | 25° | | Min Wall Thickness | 0.5 mm | | Max Wall Thickness | Based on the blank dimensions available for Vita YZ® ST Multicolor by Vita | | Min Abutment Post Height | 5 mm | | Max Abutment Post Height | Based on the blank dimensions available for Vita YZ® ST Multicolor by Vita | | Min Gingiva Heigh | 1.5 mm (given by the standardized shape of the Multi-Unit Abutment) | | Compatible cement | Multilink Hybrid by Ivoclar Vivadent (K130436) | ## Physical Characteristics Universal Base ASC Engaging and Non-Engaging: | Platform | Collar Height (mm) | | --- | --- | | NP | 1, 1.5, 2.5, 3.5 | | RP | 1, 1.5, 2.5, 3.5 | | WP | 1, 1.5, 2.5 | Temporary Abutments: | Device | Platform | Diameter (mm) | Gingival Height (mm) | Height (mm) | | --- | --- | --- | --- | --- | | Temporary Abutments Conical Connection Engaging and Non-Engaging | NP | 4.1 | 1.5, 2.5, 3.5 | 11 | | | RP | 4.3, 4.8 | 1.5, 2.5, 3.5 | 11 | | | WP | 4.8 | 1.5, 2.5 | 11 | | Healing Abutments Conical Connection | 3.0 | 3.3, 4 | 3, 5 | - | | | NP | 4, 5 | 3, 5 | - | | | RP | 4, 5, 6 | 3, 5 | - | | | WP | 5, 6.5 | 3, 5 | - | {11} N Nobel Biocare™ Screws: | Device | Platform | Shaft Diameter (mm) | Total Length (mm) | | --- | --- | --- | --- | | Long Omnigrip Screw Clinical | NP | 2.3 | 9.475 | | | RP/WP | 2.52 | 9.45 | | MUA Prosthetic Screw | NP/RP/WP | 2.3 | 4.125 | # Material compositions | Device Line | Body Material Description | Surface Treatment Description | Mesostructure and Cement | | --- | --- | --- | --- | | Universal Base ASC | Titanium-6 Aluminum-4 Vanadium alloy: 90% Ti, 6% Al, 4% V (ASTM F136 and ISO 5832-3) | full dip surface anodization | Mesostructure: VITA YZ ST (K180703) Vita Zahnfabrik H. Rauter GmbH Multilink Hybrid Abutment Cement: Ivoclar Vivadent AG (K130436) | | Temporary Abutments | Titanium-6 Aluminum-4 Vanadium alloy: 90% Ti, 6% Al, 4% V (ASTM F136 and ISO 5832-3) | full dip surface anodization | N/A | | Screws | Titanium-6 Aluminum-4 Vanadium alloy: 90% Ti, 6% Al, 4% V (ASTM F136 and ISO 5832-3) | Diamond Like Carbon (DLC) coating | N/A | ### 1.11 Intended Use/Indication for Use # **Universal Bases ASC Engaging:** Universal Bases ASC Engaging are indicated to support the placement of single unit, screw retained prosthetic restorations in the maxilla or mandible. The Universal Base consists of two major parts. Specifically, the titanium base and mesostructured components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from intra oral scanners, CAD software, CAM software, ceramic and ceramic-dominant material, milling machine and associated tooling and accessories. # **Universal Bases ASC Non-Engaging:** Universal Bases ASC Non-Engaging are indicated to support the placement of multiple unit, screw retained prosthetic restorations in the maxilla or mandible. {12} Nobel^{}[] Biocare™ The Universal Base Non-Engaging consists of multiple parts. Specifically, the titanium base and multi-unit mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from intra oral scanners, CAD software, CAM software, ceramic and ceramic-dominant material, milling machine and associated tooling and accessories. ### **Universal Bases MUA ASC:** Universal Base MUA ASC are indicated to support the placement of multiple unit, screw retained prosthetic restorations in the maxilla or mandible. The Universal Base MUA consists of three major parts, specifically the Multi-unit abutment, the Universal Base MUA and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from intra oral scanners, CAD software, CAM software, ceramic and ceramic-dominant material, milling machine and associated tooling and accessories. ### **Temporary Abutment Engaging and Non-Engaging:** Temporary Abutments Engaging CC are indicated for use with single unit screw-retained temporary dental prostheses placed on endosseous dental implants in the maxilla and mandible, for up to 180 days. Temporary Abutment Non-Engaging CC are indicated for use with multiple unit screw-retained temporary dental prosthesis placed on endosseous dental implant in the maxilla and mandible, for up to 180 days. ### **Omnigrip Clinical Screw Titanium:** Clinical Screws are indicated for use to secure a dental abutment or framework to a dental implant in the maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation. ### **Omnigrip Prosthetic Screw:** Prosthetic screws are indicated for use to secure a dental abutment or framework to a dental abutment or base in the maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation. ### **Healing Abutment Conical Connection:** {13} Nobel^{}[] Biocare™ The Healing Abutments Conical Connection are premanufactured prosthetic components to be directly connected to the endosseous dental implants or abutments and are indicated as temporary components for one single tooth to full arch denture procedures. ### 1.12 Indications for Use Comparison The Intended Use statement and Indications for Use statement are the same, differing only in the choice of words. {14} N Nobel Biocare™ ### 1.13 Technological Comparison #### 1.13.1 Universal Base ASC Table 1: Universal Base ASC Engaging, Predicate and Reference Device Summary | Characteristic | Subject Device | Predicate Device | Reference Device # 1 | Reference Device # 2 | | | --- | --- | --- | --- | --- | --- | | | Universal Base ASC Engaging | Universal Base CC | NobelProcera Titanium Abutment ASC | DESS Dental Smart Solutions | Comparison: | | | | K200040 | K233208 | K240982 | | | Manufacturer | Nobel Biocare | Nobel Biocare | Nobel Biocare | Terrats Medical SL | | | Intended Use | | | | | | | Pictorial representation |  |  |  | n/a | n/a | | Product Classification | Class II | Class II | Class II | Class II | Same as Predicate Device | | Regulation Number / Name | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | Same as Predicate Device | | | Endosseous Dental Implant Abutment | Endosseous Dental Implant Abutment | Endosseous Dental Implant Abutment | Endosseous Dental Implant Abutment | Same as Predicate Device | | Product Code, primary | NHA | NHA | NHA | NHA | Same as Predicate Device | | Product Code, secondary | PNP | PNP | n/a | n/a | Same as Predicate Device | | Review Panel | Dental | Dental | Dental | Dental | Same as Predicate Device | {15} N Nobel Biocare™ | Characteristic | Subject Device | Predicate Device | Reference Device # 1 | Reference Device # 2 | | | --- | --- | --- | --- | --- | --- | | | Universal Base ASC Engaging | Universal Base CC | NobelProcera Titanium Abutment ASC | DESS Dental Smart Solutions | Comparison: | | Intended Use | Intended to be connected to an endosseous dental implant to support the placement of a dental prosthesis | The Universal Base Conical Connection are attached to Nobel Biocare dental implants and are intended to support a crown. | Nobel Biocare's NobelProcera®/Procera® Abutment Titanium/Zirconia is a customized dental abutment. The abutment attaches directly to the endosseous dental implant with a clinical screw and provides a platform for restoration | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. | Same intended use, differing only in the choice of words | | Indications for Use | Universal Bases Conical Connection Engaging are indicated to support the placement of single unit, screw retained prosthetic restorations in the maxilla or mandible. The Universal Base consists of two major parts. Specifically, the titanium base and mesostructured components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from intra oral scanners, CAD software, CAM software, ceramic and ceramic-dominant material, milling machine and associated tooling and accessories. | The Universal Base Conical Connection is a premanufactured prosthetic component directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. The Universal Base Conical Connection consists of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. | Nobel Biocare's NobelProcera/Procera Abutment Titanium/Zirconia is indicated for the treatment of partially edentulous patients requiring prosthetic Devices and/or endosseous implants to restore chewing function. | All digitally designed custom abutments for use with DESS Bases or Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture, or to be designed and manufactured according to the digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine, and associated tooling and accessories | Same indications use, differing only in the choice of words | | Clinical setting | The finalized abutment is used in a dental practice | The finalized abutment is used in a dental practice | The finalized abutment is used in a dental practice | The finalized abutment is used in a dental practice | Same as Predicate Device | | Primary User Population | Dental healthcare professionals | Dental healthcare professionals | Dental healthcare professionals | Dental healthcare professionals | Same as Predicate Device | | Patient Population | Patients Subject to dental implant treatment | Patients Subject to dental implant treatment | Patients Subject to dental implant treatment | Patients Subject to dental implant treatment | Same as Predicate Device | | Anatomical Site | Oral cavity | Oral cavity | Oral cavity | Oral cavity | Same as Predicate Device | | Technological Characteristics | | | | | | | Device Dimensions/ Design Specifications | | | | | | {16} N Nobel Biocare™ | Characteristic | Subject Device | Predicate Device | Reference Device # 1 | Reference Device # 2 | | | --- | --- | --- | --- | --- | --- | | | Universal Base ASC Engaging | Universal Base CC | NobelProcera Titanium Abutment ASC | DESS Dental Smart Solutions | Comparison: | | Minimum wall thickness Mesostructure: | 0.5 mm | 0.8 mm | 0.4 mm | 0.4 mm | Similar as Reference Device #1 | | Minimum platform diameter | | | | | | | NP | Ø 4.1 | Ø 4.775 | Ø 3.13 | For NobelActive/ NobelReplace/ NobelParallel Conical Connection: 3.5 – 5.5 | Similar to Predicate Device | | RP | Ø 4.3 | Ø 4.775 | Ø 3.46 | | Similar to Predicate Device | | WP | Ø 4.8 | Ø 6.515 | Ø 4.486 | | Similar to Predicate Device | | Minimum gingiva height: | 1 mm | 0.275 mm | 0.3 mm | 0.5 mm | Similar to Predicate Device | | Minimum abutment post height: | 4mm (above gingival collar height) | 4mm | 4mm | 4.0 mm | Same as Predicate Device | | Screw Channel | ASC (0-25°) | Straight | ASC (0-25°) | Straight | same as Reference Device #1 | | Abutment Shape | Standardized | Standardized | Patient Specific | Patient Specific | Same as Predicate Device | | Platform compatibility | Narrow Platform (NP) | Narrow Platform (NP) | Narrow Platform (NP) | Narrow Platform (NP) | Same as Predicate Device | | | Regular Platform (RP) | Regular Platform (RP) | Regular Platform (RP) | Regular Platform (RP) | Same as Predicate Device | | | Wide Platform (WP) | Wide Platform (WP) | Wide Platform (WP) | Wide Platform (WP) | Same as Predicate Device | | Connection interface | conical connection | conical connection | conical connection | conical connection | Same as Predicate Device | | Attachment method to implant | Screw retained | Screw retained | Screw retained | Screw retained | Same as Predicate Device | | Mesostructure attachment method | Cement retained | Cement retained | Cement retained | Cement retained | Same as Predicate Device | | Restoration type | Single-unit | Single-unit | Single-unit and multi-unit | Single-unit and multi-unit | Same as Predicate Device | | Design features | 2-piece abutment Abutment premanufactured Single unit | 2-piece abutment Abutment premanufactured Single unit | Pre-manufactured implant-interface connection, customizable cylindrical abutment body | 2-piece abutment Abutment | Same as Predicate Device | | Principle of operation/ Mechanism of action | Mechanical screw connection | Mechanical screw connection | Mechanical screw connection | Not part of publicly available 510k summary. | Same as Predicate Device | | Maximum Mesostructure angulation | 20° | 20° | N/A | 30° | Same as Predicate Device | {17} N Nobel Biocare™ | Characteristic | Subject Device | Predicate Device | Reference Device # 1 | Reference Device # 2 | | | --- | --- | --- | --- | --- | --- | | | Universal Base ASC Engaging | Universal Base CC | NobelProcera Titanium Abutment ASC | DESS Dental Smart Solutions | Comparison: | | Base Material | Titanium aluminum vanadium alloy | Titanium aluminum vanadium alloy | Titanium aluminum vanadium alloy | Titanium aluminum vanadium alloy | Same as Predicate Device | | | Ti6Al4V ELI (ISO 5832-3, ASTM F136) MTA005 | Ti6Al4V ELI (ISO 5832-3, ASTM F136) MTA005 | Ti6Al4V ELI (ISO 5832-3, ASTM F136) MTA005 | Ti6Al4V ELI (ISO 5832-3, ASTM F136) MTA005 | Same as Predicate Device | | Mesostructure/Crown Material | VITA YZ ST (K180703) Vita Zahnfabrik H. Rauter GmbH | Vita Enamic IS (K153645) Vita Zahnfabrik H. Rauter GmbH | n/a | VITA YZ ST (K180703) Vita Zahnfabrik H. Rauter GmbH | Same as Reference Device #2 materials | | Adhesive Material | Multilink Hybrid Abutment Cement Ivoclar Vivadent AG (K130436) | Multilink Hybrid Abutment Cement Ivoclar Vivadent AG (K130436) | n/a | Multilink Hybrid Abutment Cement Ivoclar Vivadent AG (K130436) | Same as Predicate Device | | Surface treatment | anodized | none | anodized | Not part of publicly available 510k summary. | Same as Reference Device #1 | | Biocompatibility | biocompatible according to ISO 10993-1 | biocompatible according to ISO 10993-1 | biocompatible according to ISO 10993-1 | biocompatible according to ISO 10993-5, -12 | Same as Predicate Device | | Tissue contact | Permanent contact with bone and soft tissue | Permanent contact with bone and soft tissue | Permanent contact with bone and soft tissue | Not part of publicly available 510k summary. | Same as Predicate Device | | Digital design workflow | Creation of patient scan at dental practice | Creation of patient scan at dental practice | n/a | Not part of publicly available 510k summary. | Same as Predicate Device | | | Export of scan to design software | Export of scan to design software | n/a | | Same as Predicate Device | | | Design of customization of abutment according to design restrictions | Design of customization of abutment according to design restrictions | n/a | | Same as Predicate Device | | Equipment for digital design workflow | | | | | | | Scanner | 3Shape intra oral scanner Trios (3Shape A/S) or other scanners with accuracy equal or higher. | 3Shape intra oral scanner Trios (3Shape A/S) | n/a | 3Shape intra oral scanner Trios (3Shape A/S) 3Shape desktop scanner D900 Dental Lab Scanner | Same as Predicate Device | | Design Workflow | CAD | CAD | Wax-up or CAD. | CAD | Same as Predicate Device | | CAD design software: | 3Shape (K151455) | 3Shape (K151455) | 3Shape (K151455) | 3Shape (K151455) | Same as Predicate Device | | | | | DTX Studio Lab (K181932) | | | | | ExoCAD (K193352) | ExoCAD (K193352)^{1} | ExoCAD (K193352) | ExoCAD (K193352) | | $^{1}$ Nobel Biocare has added the ExoCAD library and categorized the change as non-significant, the addition the libraries to 510k cleared software does not change the safety or effectiveness of the Device. {18} N Nobel Biocare™ | Characteristic | Subject Device | Predicate Device | Reference Device # 1 | Reference Device # 2 | | | --- | --- | --- | --- | --- | --- | | | Universal Base ASC Engaging | Universal Base CC | NobelProcera Titanium Abutment ASC | DESS Dental Smart Solutions | Comparison: | | Manufacturing Workflow | Milling unit CORITEC by imes-icore | Milling unit CORITEC by imes-icore | Customization milled at Device manufacturer. | Milling unit VHF R5 by vhf camfacture AG with DentalCAM and DentalCNC 7 software | Same as Predicate Device | | Sterility | Provided non-sterile – terminally sterilized via autoclave prior to implantation | Provided non-sterile – terminally sterilized via autoclave prior to implantation | Provided non-sterile – terminally sterilized via autoclave prior to implantation | Provided non-sterile | Same as Predicate Device | | Single Use or Reusable | Single use | Single use | Single use | Single use | Same as Predicate Device | | MRI compatibility | MR Conditional | MR Conditional | MR Conditional | MR Conditional | Same as Predicate Device | | | (cleared in K212125) | (cleared in K212125) | (cleared in K212125) | | Same as Predicate Device | | Packaging | | | | | | | Packaging | Thermoformed polyethylene terephthalate glycol (PETG) blister tray with medical paper lid forming a sterile barrier.^{2} | Thermoformed polyethylene terephthalate glycol (PETG) blister tray with medical paper lid forming a sterile barrier. | Procera packaging | Not part of publicly available 510k summary. | Same as Predicate Device | | Co-Packing | co-packed with screw | co-packed with screw | Screw | Not part of publicly available 510k summary. | Same as Predicate Device | | Fatigue Testing | Dynamic Fatigue Testing per ISO 14801 | Dynamic Fatigue Testing per ISO 14801 | Dynamic Fatigue Testing per ISO 14801 | Not part of publicly available 510k summary. | Same as Predicate Device | 2 Packaging system reviewed and cleared with K243834 {19} Nobel Biocare™ **Table 2: Universal Base ASC Non-Engaging Predicate and Reference Device Summary** | Characteristic | Subject Device | Predicate Device (Reference Device #3) | Reference Device #4 | Reference Device #1 | Reference Device #2 | Comparison: | | --- | --- | --- | --- | --- | --- | --- | | | Universal Base Non-Engaging | N1 Base Xeal + Universal Abutment N1 Base Tri Bridge | Elos Accurate Hybrid Base (Universal Base non-engaging Elos) | NobelProcera Titanium Abutment ASC | DESS Dental Smart Solutions | | | | | K211109 | K201860 | K233208 | K240982 | | | Manufacturer | Nobel Biocare | Nobel Biocare | Elos | Nobel Biocare | Terrats Medical SL | | | Intended Use | | | | | | | | Pictorial representation | | | | | n/a | n/a | | Product Classification | Class II | Class II | Class II | Class II | Class II | Same as Predicate Device (Reference Device #3) | | Regulation Number / Name | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | Same as Predicate Device (Reference Device #3) | | | Endosseous Dental Implant Abutment | Endosseous Dental Implant Abutment | Endosseous Dental Implant Abutment | Endosseous Dental Implant Abutment | Endosseous Dental Implant Abutment | Same as Predicate Device (Reference Device #3) | | Product Code, primary | NHA | NHA | NHA | NHA | NHA | Same as Predicate Device (Reference Device #3) | | Product Code, secondary | PNP | PNP | PNP | N/A | N/A | Same as Predicate Device (Reference Device #3) | | Review Panel | Dental | Dental | Dental | Dental | Dental | Same as Predicate Device (Reference Device #3) | | Intended Use | Intended to be connected to an endosseous dental implant to support the placement of a dental prosthesis | Intended to be connected to an endosseous dental implant to support the | Support of a prosthesis to restore chewing function | IFU3010: Nobel Biocare's NobelProcera®/Procera® Abutment Titanium/Zirconia is a customized dental abutment. The abutment | *DESS Dental Smart Solutions abutments are intended to be used in* | Same intended use, differing only in the choice of words | {20} Nobel Biocare™ | Characteristic | Subject Device | Predicate Device (Reference Device #3) | Reference Device #4 | Reference Device #1 | Reference Device #2 | Comparison: | | --- | --- | --- | --- | --- | --- | --- | | | **Universal Base Non-Engaging** | **N1 Base Xea + Universal Abutment N1 Base Tri Bridge** | **Elos Accurate Hybrid Base (Universal Base non-engaging Elos)** | **NobelProcera Titanium Abutment ASC** | **DESS Dental Smart Solutions** | | | | | placement of a dental prosthesis. | | attaches directly to the endosseous dental implant with a clinical screw and provides a platform for restoration | *conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.* | | | **Indications for Use** | Universal Bases Conical Connection Non-Engaging are indicated to support the placement of multiple unit, screw retained prosthetic restorations in the maxilla or mandible. The Universal Base Non-Engaging consists of multiple parts. Specifically, the titanium base and multi-unit mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from intra oral scanners, CAD software, CAM software, ceramic and ceramic-dominant material, milling machine and associated tooling and accessories | The Universal Abutment Nobel Biocare N1™ Base consist of three major parts. Specifically, the N1 Base Xea, the Universal Abutment N1 Base, and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. Nobel Biocare N1™ Base Xea™ The Nobel Biocare N1™ Base Xea™ is indicated for use in the maxilla or mandible for supporting tooth replacements to restore chewing function. It is indicated | The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1: The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are only intended to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. | Nobel Biocare's NobelProcera/Procera Abutment Titanium/Zirconia is indicated for the treatment of partially edentulous patients requiring prosthetic Devices and/or endosseous implants to restore chewing function. | *All digitally designed custom abutments for use with DESS Bases or Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture, or to be designed and manufactured according to the digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine, and associated tooling and accessories* | Same indications for use, differing only in the choice of words | {21} **Nobel Biocare™** | Characteristic | Subject Device | Predicate Device (Reference Device #3) | Reference Device #4 | Reference Device #1 | Reference Device #2 | Comparison: | | --- | --- | --- | --- | --- | --- | --- | | | **Universal Base Non-Engaging** | **N1 Base Xeal + Universal Abutment N1 Base Tri Bridge** | **Elos Accurate Hybrid Base (Universal Base non-engaging Elos)** | **NobelProcera Titanium Abutment ASC** | **DESS Dental Smart Solutions** | | | | | for single unit restorations and multiple unit restorations up to 6 units with less than 20° divergence to allow path of insertion. Universal Abutment Nobel Biocare N1™ Base Tri Bridge The Universal Abutment Nobel Biocare N1™ Base Tri Bridge is indicated to support the placement of multiple unit of up to 6 units, screw-retained prosthetic restorations in the maxilla or mandible for implants with less than 20° overall divergences to allow path of insertion. | | | | | | **Clinical setting** | The finalized abutment is used in a dental practice | The finalized abutment is used in a dental practice | N/A | The finalized abutment is used in a dental practice | The finalized abutment is used in a dental practice | Same as Predicate Device (Reference Device #3) | | **Primary User Population** | Dental healthcare professionals | Dental healthcare professionals | N/A | Dental healthcare professionals | Dental healthcare professionals | Same as Predicate Device (Reference Device #3) | | **Patient Population** | Patients Subject to dental implant treatment | Patients Subject to dental implant treatment | N/A | Patients Subject to dental implant treatment | Patients Subject to dental implant treatment | Same as Predicate Device (Reference Device #3) | | **Anatomical Site** | Oral cavity | Oral cavity | N/A | Oral cavity | Oral cavity | Same as Predicate Device (Reference Device #3) | | **Technological Characteristics** | | | | | | | | **Device Dimensions/ Design Specifications** | | | | | | | {22} N Nobel Biocare™ | Characteristic | Subject Device | Predicate Device (Reference Device #3) | Reference Device #4 | Reference Device #1 | Reference Device #2 | Comparison: | | --- | --- | --- | --- | --- | --- | --- | | | Universal Base Non-Engaging | N1 Base Xeal + Universal Abutment N1 Base Tri Bridge | Elos Accurate Hybrid Base (Universal Base non-engaging Elos) | NobelProcera Titanium Abutment ASC | DESS Dental Smart Solutions | | | Minimum wall thickness: | 0.5 mm | Circular: 0.5 mm Margin: 0.35 mm | 0.5 mm | 0.42 mm | 0.4 mm | Same as Predicate Device (Reference Device #3) | | Minimum platform diameter | | | | | | | | NP | Ø 4.1mm | Ø 4.8 mm | 3.0 - 6.0 mm | Ø 3.13 mm | For NobelActive/ NobelReplace/ NobelParallel Conical Connection: 3.5 – 5.5 | Similar to Predicate Device (Reference Device #3) | | RP | Ø 4.3mm | Ø 5.0 mm | | Ø 3.46 mm | | | | WP | Ø 4.8mm | n/a | | Ø 4.486 mm | | | | Minimum gingiva height: | 1 mm | n/a | 0.5 mm | 0.3 mm | 0.5 mm | Similar as Predicated Device (Reference Device #3) | | Minimum abutment post height: | 4mm (above gingival collar height) | 5.2 mm | 4mm | 4mm | 4.0 mm | In range of Predicate Device (Reference Device #3) and Reference Device #4 | | Screw Channel | ASC (0-25°) | straight | straight | ASC (0-25°) | Straight | Same as Reference Device #1 | | Abutment Shape | Standardized | Standardized | Standardized | Patient Specific | Patient Specific | Same as Predicate Device (Reference Device #3) | | Platform compatibility | Narrow Platform (NP) | Narrow Platform (NP) | Narrow Platform (NP) | Narrow Platform (NP) | Narrow Platform (NP) | Same as Predicate Device (Reference Device #3) | | | Regular Platform (RP) | Regular Platform (RP) | Regular Platform (RP) | Regular Platform (RP) | Regular Platform (RP) | Same as Predicate Device (Reference Device #3) | | | Wide Platform (WP) | N/A | Wide Platform (WP) | Wide Platform (WP) | Wide Platform (WP) | Same as Predicate Device (Reference Device #3) | | Connection interface | conical connection | trioval conical connection | conical connection | conical connection | conical connection | Same as Reference Device #4 | | Attachment method to implant | Screw retained | Screw retained | Screw retained | Screw retained | Screw retained | Same as Predicate Device (Reference Device #3) | | Mesostructure attachment method | Cement retained | Cement retained | Cement retained | Cement retained | Cement retained | Same as Predicate Device (Reference Device #3) | | Restoration type | multi-unit | multi-unit | Single-unit and multi-unit | Single-unit and multi-unit | Single-unit and multi-unit | Same as Predicate Device (Reference Device #3) | | Design features | 2-piece abutment Abutment, premanufactured, Multi-unit | 3-piece abutment. Abutment, premanufactured, Multi-unit | 2 piece - zirconia bonded to hybrid base mounted on to the implant and fixe with a screw | Pre-manufactured implant- interface connection, customizable cylindrical abutment body | 2-piece abutment Abutment | Same as Reference Device #4 | | Principle of operation/ Mechanism of action | Mechanical screw connection | Mechanical screw connection | Mechanical screw connection | Mechanical screw connection | Not part of publicly available 510k summary. | Same as Predicate Device (Reference Device #3) | {23} N Nobel Biocare™ | Characteristic | Subject Device | Predicate Device (Reference Device #3) | Reference Device #4 | Reference Device #1 | Reference Device #2 | Comparison: | | --- | --- | --- | --- | --- | --- | --- | | | Universal Base Non-Engaging | N1 Base Xeal + Universal Abutment N1 Base Tri Bridge | Elos Accurate Hybrid Base (Universal Base non-engaging Elos) | NobelProcera Titanium Abutment ASC | DESS Dental Smart Solutions | | | Maximum Mesostructure angulation | 20° | 20° | 20° | 30° | 30° | Same as Predicate Device (Reference Device #3) | | Base Material | Titanium aluminium vanadium alloy | Titanium aluminium vanadium alloy | Titanium aluminium vanadium alloy | Titanium aluminium vanadium alloy | Titanium aluminium vanadium alloy | Same as Predicate Device (Reference Device #3) | | | Ti6Al4V ELI (ISO 5832-3, ASTM F136) | Ti6Al4V ELI (ISO 5832-3, ASTM F136) | Ti6Al4V ELI (ISO 5832-3, ASTM F136) | Ti6Al4V ELI (ISO 5832-3, ASTM F136) | Ti6Al4V ELI (ISO 5832-3, ASTM F136) | Same as Predicate Device (Reference Device #3) | | Mesostructure Material | VITA YZ ST (K180703) Vita Zahnfabrik H. Rauter GmbH | Zirconia Nacera Pearl (K143071) Doceram Medical Ceramics GmbH | 3M Lava Plus Zirconia (K011394) | n/a | VITA YZ ST (K180703) Vita Zahnfabrik H. Rauter GmbH | Same as Reference Device #2 | | Adhesive Material | Multilink Hybrid Abutment Cement Ivoclar Vivadent AG (K130436) | Multilink Hybrid Abutment Cement Ivoclar Vivadent AG (K130436) | Multilink Hybrid Abutment Cement Ivoclar Vivadent AG (K130436) | n/a | Multilink Hybrid Abutment Cement Ivoclar Vivadent AG (K130436) | Same as Predicate Device (Reference Device #3) | | Surface treatment | anodized | anodized | n/a | anodized | Not part of publicly available 510k summary | Same as Reference Device #1 | | Biocompatibility | biocompatible according to ISO 10993-1 | biocompatible according to ISO 10993-1 | biocompatible according to ISO 10993-5 | biocompatible according to ISO 10993-1 | biocompatible according to ISO 10993-5, -12 | Same as Predicate Device (Reference Device #3) | | Tissue contact | Permanent contact with bone and soft tissue | Permanent contact with bone and soft tissue | n/a | Permanent contact with bone and soft tissue | Not part of publicly available 510k summary | Same as Predicate Device (Reference Device #3) | | Digital design workflow | Creation of patient scan at dental practice | Creation of patient scan at dental practice | n/a | Customization milled at Device manufacturer | Not part of publicly available 510k summary | Same as Predicate Device (Reference Device #3) | | | Export of scan to design software | Export of scan to design software | | | | Same as Predicate Device (Reference Device #3) | | | Design of customization of abutment according to design restrictions | Design of customization of abutment according to design restrictions | | | | Same as Predicate Device (Reference Device #3) | | Equipment for digital design workflow | | | | | | | | Scanner | 3Shape intra oral scanner Trios (3Shape A/S) or other scanners with accuracy equal or higher | 3Shape intra oral scanner Trios (3Shape A/S) | 3Shape intra oral scanner Trios (3Shape A/S) | n/a | 3Shape intra oral scanner Trios (3Shape A/S) | Same as Predicate Device (Reference Device #3) | {24} Nobel Biocare™ | Characteristic | Subject Device | Predicate Device (Reference Device #3) | Reference Device #4 | Reference Device #1 | Reference Device #2 | Comparison: | | --- | --- | --- | --- | --- | --- | --- | | | Universal Base Non-Engaging | N1 Base Xeal + Universal Abutment N1 Base Tri Bridge | Elos Accurate Hybrid Base (Universal Base non-engaging Elos) | NobelProcera Titanium Abutment ASC | DESS Dental Smart Solutions | | | | | | | | 3Shape desktop scanner D900 Dental Lab Scanner | | | Design Workflow | CAD | CAD | CAD | Wax-up or CAD. | CAD | Same as Predicate Device (Reference Device #3) | | CAD design software | 3Shape (K151455) | Design software: DTX Studio Design (K181932, where the implant libraries are automatically included in the software installer) or 3Shape Abutment Designer Software (K151455, where the implant libraries are obtained via the 3Shape server in the software). | Design software 3Shape Abutment Designer Software (K151455, where the implant libraries are obtained via the 3Shape server in the software). | 3Shape (K151455), or DTX Studio Lab (K181932) | 3Shape (K151455) | Same as Reference Device #2 | | | ExoCAD (K193352) | | | ExoCAD (K193352) | ExoCAD (K193352) | Same as Predicate Device (Reference Device #3) | | Manufacturing Workflow | Milling unit CORiTEC by imes-icore | Milling unit - Indicated for Zirconia milling - Minimum 5 axis milling technology - Minimum 30.000 rpm spindle speed | Milling unit CORiTEC by imes-icore | Customization milled at Device manufacturer. | Milling unit VHF R5 by vhf camfacture AG with DentalCAM and DentalCNC 7 software | Same as Reference Device #4 | | Sterility | Provided non-sterile – terminally sterilized via autoclave prior to implantation | N1 Base Xeal: provided sterile – Gamma Radiation SAL 10^{-6} Universal Abutment N1 Base Bridge; Provided non-sterile – terminally sterilized via autoclave prior to implantation | n/a | Provided non-sterile – terminally sterilized via autoclave prior to implantation | Provided non-sterile | Same as Predicate Device (Reference Device #3) | | Single Use or Reusable | Single use | Single use | Single use | Single use | Single use | Same as Predicate Device (Reference Device #3) | | MRI compatibility | MR Conditional | MR Conditional | n/a | MR Conditional | MR Conditional | Same as Predicate Device (Reference Device #3) | {25} **Nobel Biocare™** | Characteristic | Subject Device | Predicate Device (Reference Device #3) | Reference Device #4 | Reference Device #1 | Reference Device #2 | Comparison: | | --- | --- | --- | --- | --- | --- | --- | | | **Universal Base Non-Engaging** | **N1 Base Xeal + Universal Abutment N1 Base Tri Bridge** | **Elos Accurate Hybrid Base (Universal Base non-engaging Elos)** | **NobelProcera Titanium Abutment ASC** | **DESS Dental Smart Solutions** | | | | (cleared in K212125) | (cleared in K212125) | n/a | (cleared in K212125) | n/a | Same as Predicate Device (Reference Device #3) | | **Packaging** | | | | | | | | **Packaging** | Thermoformed polyethylene terephthalate glycol (PETG) blister tray with medical paper lid forming a sterile barrier. | Thermoformed polyethylene terephthalate glycol (PETG) blister tray with medical paper lid forming a sterile barrier. | n/a | Procera packaging | Not part of publicly available 510k summary. | Same as Predicate Device (Reference Device #3) | | **Co-Packing** | co-packed with screw | co-packed with screw | n/a | co-packed with screw | Not part of publicly available 510k summary. | Same as Predicate Device (Reference Device #3) | | **Fatigue Testing** | Dynamic Fatigue Testing per ISO 14801 | Dynamic Fatigue Testing per ISO 14801 | n/a | Dynamic Fatigue Testing per ISO 14801 | Not part of publicly available 510k summary. | Same as Predicate Device (Reference Device #3) | {26} N Nobel Biocare™ Table 3: Universal Base MUA ASC Predicate and Reference Device Summary | Characteristic | Subject Device | Predicate Device (Reference Device #3) | Reference Device #1 | Reference Device #2 | Comparison: | | --- | --- | --- | --- | --- | --- | | | Multi-unit Abutment Conical Connection Xeal + Universal Base MUA | N1 Base Xeal + Universal Abutment N1 Base Tri Bridge | NobelProcera Titanium Abutment ASC | DESS Dental Smart Solutions | | | | Nobel Biocare | Nobel Biocare | Nobel Biocare | K240982 | | | Intended Use | | K211109 | K233208 | Terrats Medical SL | | | Pictorial representation | | | | n/a | n/a | | Product Classification | Class II | Class II | Class II | Class II | Same as Predicate Device (Reference Device #3) | | Regulation Number / Name | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | Same as Predicate Device (Reference Device #3) | | | Endosseous Dental Implant Abutment | Endosseous Dental Implant Abutment | Endosseous Dental Implant Abutment | Endosseous Dental Implant Abutment | Same as Predicate Device (Reference Device #3) | | Product Code, primary | NHA | NHA | NHA | NHA | Same as Predicate Device (Reference Device #3) | | Product Code, secondary | PNP | PNP | N/A | N/A | Same as Predicate Device (Reference Device #3) | | Review Panel | Dental | Dental | Dental | Dental | Same as Predicate Device (Reference Device #3) | | Intended Use | Intended to be connected to an endosseous dental implant to support the placement of a dental prosthesis | Intended to be connected to an endosseous dental implant to support the placement of a dental prosthesis. | IFU3010: Nobel Biocare's NobelProcera®/Procera® Abutment Titanium/Zirconia is a customized dental abutment. The abutment attaches directly to the endosseous dental implant with a clinical screw and provides a platform for restoration | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. All digitally designed custom abutments for use with DESS Bases or Pre-milled Blanks are to be sent to a | Same intended use, differing only in the choice of words | | Indications for Use | Universal Bases Conical Connection Non-Engaging and Universal Base MUA are indicated | The Universal Abutment Nobel Biocare N1™ Base consist of three major parts. Specifically, the N1 Base Xeal, the | Nobel Biocare's NobelProcera/Procera Abutment Titanium/Zirconia | | Same indications use, differing only in the choice of words | {27} N Nobel Biocare™ | Characteristic | Subject Device | Predicate Device (Reference Device #3) | Reference Device #1 | Reference Device #2 | Comparison: | | --- | --- | --- | --- | --- | --- | | | **Multi-unit Abutment Conical Connection Xeal + Universal Base MUA** | **N1 Base Xeal + Universal Abutment N1 Base Tri Bridge** | **NobelProcera Titanium Abutment ASC** | **DESS Dental Smart Solutions** | | | | to support the placement of multiple unit, screw retained prosthetic restorations in the maxilla or mandible. The Universal Base MUA consists of three major parts, specifically the Multi-unit abutment, the Universal Base MUA and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from intra oral scanners, CAD software, CAM software, ceramic and ceramic-dominant material, milling machine and associated tooling and accessories | Universal Abutment N1 Base, and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. Nobel Biocare N1™ Base Xeal™ The Nobel Biocare N1™ Base Xeal™ is indicated for use in the maxilla or mandible for supporting tooth replacements to restore chewing function. It is indicated for single unit restorations and multiple unit restorations up to 6 units with less than 20° divergence to allow path of insertion. Universal Abutment Nobel Biocare N1™ Base Tri Bridge The Universal Abutment Nobel Biocare N1™ Base Tri Bridge is indicated to support the placement of multiple unit of up to 6 units, screw-retained prosthetic restorations in the maxilla or mandible for implants with less than 20° overall divergences to allow path of insertion. | is indicated for the treatment of partially edentulous patients requiring prosthetic Devices and/or endosseous implants to restore chewing function. | *Terrats Medical validated milling center for manufacture, or to be designed and manufactured according to the digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine, and associated tooling and accessories* | | | **Clinical setting** | The finalized abutment is used in a dental practice | The finalized abutment is used in a dental practice | The finalized abutment is used in a dental practice | The finalized abutment is used in a dental practice | Same as Predicate Device (Reference Device #3) | | **Primary User Population** | Dental healthcare professionals | Dental healthcare professionals | Dental healthcare professionals | Dental healthcare professionals | Same as Predicate Device (Reference Device #3) | | **Patient Population** | Patients Subject to dental implant treatment | Patients Subject to dental implant treatment | Patients Subject to dental implant treatment | Patients Subject to dental implant treatment | Same as Predicate Device (Reference Device #3) | | **Anatomical Site** | Oral cavity | Oral cavity | Oral cavity | Oral cavity | Same as Predicate Device (Reference Device #3) | | **Technological Characteristics** | | | | | | {28} N Nobel Biocare™ | Characteristic | Subject Device | Predicate Device (Reference Device #3) | Reference Device #1 | Reference Device #2 | Comparison: | | --- | --- | --- | --- | --- | --- | | | Multi-unit Abutment Conical Connection Xeal + Universal Base MUA | N1 Base Xeal + Universal Abutment N1 Base Tri Bridge | NobelProcera Titanium Abutment ASC | DESS Dental Smart Solutions | | | Device Dimensions/ Design Specifications | | | | | | | Minimum wall thickness | 0.5 mm | Circular: 0.5 mm Margin: 0.35 mm | 0.42 mm | 0.4 mm | Same as Predicate Device (Reference Device #3) | | Minimum platform diameter | | | | | | | NP/RP/WP | NP/RP/WP Ø 5 | NP Ø 4.8 RP Ø 5 | Ø 3.13 - Ø 4.486 | For NobelActive/ NobelReplace/ NobelParallel Conical Connection: 3.5 – 5.5 | Same as Predicate Device (Reference Device #3) | | Minimum gingival height | 1.5 mm | 1.5 mm | 0.3 mm | 0.5 mm | Same as Predicate Device (Reference Device #3) | | Minimum abutment post height: | 5mm (above gingival collar height) | 5.2 mm | 4mm | 4.0 mm | Similar to Predicate Device (Reference Device #3) and Reference Device #1 | | Screw Channel | ASC (0-25°) | straight | ASC (0-25°) | Straight | Same as Reference Device #1 | | Abutment Shape | Standardized | Standardized | Patient Specific | Patient Specific | Same as Predicate Device (Reference Device #3) | | Platform compatibility | Compatible with Nobel Biocare Conical Connection Multi-unit Abutment platforms NP, RP and WP | Narrow Platform (NP) | Narrow Platform (NP) | Narrow Platform (NP) | Same as Reference Device #1 | | | | Regular Platform (RP) | Regular Platform (RP) | Regular Platform (RP) | | | | | n/a | Wide Platform (WP) | Wide Platform (WP) | | | Connection interface | Multi-unit Abutment: conical connection Universal Base MUA: Multi-unit Abutment | Trioval conical connection | conical connection | conical connection | Same as Reference Device #1 | | Attachment method to implant | Screw retained | Screw retained | Screw retained | Screw retained | Same as Predicate Device (Reference Device #3) | | Mesostructure attachment method | Cement retained | Cement retained | Cement retained | Cement retained | Same as Predicate Device (Reference Device #3) | | Restoration type | Multi-unit | multi-unit | Single-unit and multi-unit | Single-unit and multi-unit | Same as Predicate Device (Reference Device #3) | {29} N Nobel Biocare™ | Characteristic | Subject Device | Predicate Device (Reference Device #3) | Reference Device #1 | Reference Device #2 | Comparison: | | --- | --- | --- | --- | --- | --- | | | Multi-unit Abutment Conical Connection Xeal + Universal Base MUA | N1 Base Xeal + Universal Abutment N1 Base Tri Bridge | NobelProcera Titanium Abutment ASC | DESS Dental Smart Solutions | | | Design features | Multi-piece abutment Abutment premanufactured Single or Multi-unit | 3-piece abutment. Abutment premanufactured Multi-unit | Pre-manufactured implant-interface connection, customizable cylindrical abutment body | 2-piece abutment Abutment | Same as Predicate Device (Reference Device #3) | | Principle of operation/ Mechanism of action | Mechanical screw connection | Mechanical screw connection | Mechanical screw connection | Not part of publicly available 510k summary. | Same as Predicate Device (Reference Device #3) | | Maximum Mesostructure angulation | 20° | 20° | 30° | 30° | Same as Predicate Device (Reference Device #3) | | Material Base | Titanium aluminum vanadium alloy | Titanium aluminium vanadium alloy | Titanium aluminum vanadium alloy | Titanium aluminium vanadium alloy | Same as Predicate Device (Reference Device #3) | | | Ti6Al4V ELI (ISO 5832-3, ASTM F136) MTA005 | Ti6Al4V ELI (ISO 5832-3, ASTM F136) MTA005 | Ti6Al4V ELI (ISO 5832-3, ASTM F136) MTA005 | Ti6Al4V ELI (ISO 5832-3, ASTM F136) MTA005 | Same as Predicate Device (Reference Device #3) | | Mesostructure/Crown Material | VITA YZ ST (K180703) Vita Zahnfabrik H. Rauter GmbH | Zirconia Nacera Pearl (K143071) Doceram Medical Ceramics GmbH | n/a | VITA YZ ST (K180703) Vita Zahnfabrik H. Rauter GmbH | Same as Reference Device #2 | | Adhesive Material | Multilink Hybrid Abutment Cement Ivoclar Vivadent AG (K130436) | Multilink Hybrid Abutment Cement Ivoclar Vivadent AG (K130436) | Multilink Hybrid Abutment Cement Ivoclar Vivadent AG (K130436) | Multilink Hybrid Abutment Cement Ivoclar Vivadent AG (K130436) | Same as Predicate Device (Reference Device #3) | | Surface treatment | anodized | anodized | anodized | Not part of publicly available 510k summary. | Same as Predicate Device (Reference Device #3) | | Biocompatibility | biocompatible according to ISO 10993-1 | biocompatible according to ISO 10993-1 | biocompatible according to ISO 10993-1 | biocompatible according to ISO 10993-5, -12 | Same as Predicate Device (Reference Device #3) | | Tissue contact | Permanent contact with bone and soft tissue | Permanent contact with bone and soft tissue | Permanent contact with bone and soft tissue | Not part of publicly available 510k summary. | Same as Predicate Device (Reference Device #3) | | Digital design workflow | Creation of patient scan at dental practice | Creation of patient scan at dental practice | Creation of patient scan at dental practice | Not part of publicly available 510k summary. | Same as Predicate Device (Reference Device #3) | | | Export of scan to design software | Export of scan to design software | Export of scan to design software | | Same as Predicate Device (Reference Device #3) | | | Design of customization of abutment according to design restrictions | Design of customization of abutment according to design restrictions | Design of customization of abutment according to design restrictions | | Same as Predicate Device (Reference Device #3) | | Equipment for digital design workflow | | | | | | {30} N Nobel Biocare™ | Characteristic | Subject Device | Predicate Device (Reference Device #3) | Reference Device #1 | Reference Device #2 | Comparison: | | --- | --- | --- | --- | --- | --- | | | Multi-unit Abutment Conical Connection Xeal + Universal Base MUA | N1 Base Xeal + Universal Abutment N1 Base Tri Bridge | NobelProcera Titanium Abutment ASC | DESS Dental Smart Solutions | | | Scanner: | 3Shape intra oral scanner Trios (3Shape A/S) or other scanners with accuracy equal or higher | 3Shape intra oral scanner Trios (3Shape A/S) | n/a | 3Shape intra oral scanner Trios (3Shape A/S) 3Shape desktop scanner D900 Dental Lab Scanner | Same as Predicate Device (Reference Device #3) | | Design Workflow | CAD | CAD | Wax-up or CAD. | CAD | Same as Predicate Device (Reference Device #3) | | CAD design software | 3Shape (K151455) | Design software: DTX Studio Design (K181932, where the implant libraries are automatically included in the software installer) or 3Shape Abutment Designer Software (K151455, where the implant libraries are obtained via the 3Shape server in the software). | 3Shape (K151455) | 3Shape (K151455) | Same as Predicate Device (Reference Device #3) | | | | | DTX Studio Lab (K181932) | | | | | ExoCAD (K193352) | | ExoCAD (K193352) | ExoCAD (K193352) | Same as Reference Device #1 | | Manufacturing Workflow | Milling unit CORITEC by imes-icore | Milling unit - Indicated for Zirconia milling - Minimum 5 axis milling technology - Minimum 30.000 rpm spindle speed | Customization milled at Device manufacturer. | Milling unit VHF R5 by vhf camfacture AG with DentalCAM and DentalCNC 7 software | Same as Predicate Device (Reference Device #3) | | Sterility | Provided non-sterile – terminally sterilized via autoclave prior to implantation | N1 Base Xeal: provided sterile – Gamma Radiation SAL 10^{-6} Universal Abutment N1 Base Bridge; Provided non-sterile – terminally sterilized via autoclave prior to implantation | Provided non-sterile – terminally sterilized via autoclave prior to implantation | Provided non-sterile | Same as Reference Device #1 | | Single Use or Reusable | Single use | Single use | Single use | Single use | Same as Predicate Device (Reference Device #3) | | MRI compatibility | MR Conditional | MR Conditional | MR Conditional | MR Conditional | Same as Predicate Device (Reference Device #3) | | | (cleared in K212125) | (cleared in K212125) | (cleared in K212125) | | Same as Predicate Device (Reference Device #3) | | Packaging | | | | | | | Packaging | Thermoformed polyethylene terephthalate glycol (PETG) blister tray with medical paper lid forming a sterile barrier. | Thermoformed polyethylene terephthalate glycol (PETG) blister tray with medical paper lid forming a sterile barrier. | Procera packaging | Not part of publicly available 510k summary. | Same as Predicate Device (Reference Device #3) | | Co-Packing | co-packed with screw | co-packed with screw | Screw | Not part of publicly available 510k summary. | Same as Predicate Device (Reference Device #3) | {31} [LOGO] Nobel Biocare™ | Characteristic | Subject Device | Predicate Device (Reference Device #3) | Reference Device #1 | Reference Device #2 | Comparison: | | --- | --- | --- | --- | --- | --- | | | Multi-unit Abutment Conical Connection Xeal + Universal Base MUA | N1 Base Xeal + Universal Abutment N1 Base Tri Bridge | NobelProcera Titanium Abutment ASC | DESS Dental Smart Solutions | | | Fatigue Testing | Dynamic Fatigue Testing per ISO 14801 | Dynamic Fatigue Testing per ISO 14801 | Dynamic Fatigue Testing per ISO 14801 | Not part of publicly available 510k summary. | Same as Predicate Device (Reference Device #3) | The similarities between the Subject device line Universal Base ASC Engaging, Non-Engaging and MUA ASC and the Primary Predicate (and Reference Devices # 1, 2, 3 and 4) Device are as follows: - The Intended Use statement and Indications for Use statement are the same, differing only in the choice of words - Principle of operations, design features and workflow, attachment methods, device material, compatible devices are the same or similar for the Subject Devices and the Predicate Devices. Furthermore, all the Subject and Predicate Devices are non-sterile, single-use devices. - Subject Device Lines and the Primary Predicate Devices are labelled MR Conditional Details of the Differences Between the Subject and Predicate Device: There are no significant differences between the Subject and predicate devices but there are minor differences as follows: - The dimensions are different in the Subject and Predicate device but remain in the range of the Predicate Device and Reference Device. - Compared to the Predicate Device, the Subject Device is provided with anodization, an angulated screw channel and connection interface, in addition the Subject Device can be used with a different in-lab milling unit then the Predicate. ### Conclusion: Based on a comparison of intended use, indications for use, technological characteristics, principle of operation, features, and performance data, the device line Universal Base ASC is deemed to be substantially equivalent to the Primary Predicate Device. The new devices do not introduce a fundamentally new scientific technology and the non-clinical tests demonstrate that the devices are substantially equivalent. {32} Nobel Biocare™ ### 1.13.2 Temporary Abutments **Table 4: Temporary Abutment Engaging and Non-Engaging Predicate and Reference Device Summary** | Characteristic | Subject Device | Predicate Device (Reference Device #5) | Reference Device #6 | Comparison: | | --- | --- | --- | --- | --- | | | Temporary Abutments Engaging and Non-Engaging Conical Connection | Temporary Abutment Nobel Biocare N1™ TCC | Temporary Snap Abutment (Engaging and Non-Engaging) | | | | | **K211109** | **K161435** | | | Manufacturer | Nobel Biocare | Nobel Biocare | Nobel Biocare | | | Intended Use | | | | | | Pictorial Representation | | | | n/a | | Product Classification | Class II | Class II | Class II | Same as Predicate Device (Reference Device #5) | | Regulation Number / Name | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | Same as Predicate Device (Reference Device #5) | | | Endosseous Dental Implant Abutment | Endosseous Dental Implant Abutment | Endosseous Dental Implant Abutment | Same as Predicate Device (Reference Device #5) | | Product Code, primary | NHA | NHA | NHA | Same as Predicate Device (Reference Device #5) | | Review Panel | Dental | Dental | Dental | Same as Predicate Device (Reference Device #5) | | Intended Use | Intended to be connected to an endosseous dental implant to support the placement of a dental prosthesis | Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. | Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. | Same intended use, differing only in the choice of words | {33} N Nobel Biocare™ | Characteristic | Subject Device | Predicate Device (Reference Device #5) | Reference Device #6 | Comparison: | | --- | --- | --- | --- | --- | | | Temporary Abutments Engaging and Non-Engaging Conical Connection | Temporary Abutment Nobel Biocare N1™ TCC | Temporary Snap Abutment (Engaging and Non-Engaging) | | | | | K211109 | K161435 | | | Indications for Use | Temporary Abutment Engaging and Non-Engaging Temporary Abutments Engaging CC are indicated for use with single unit screw-retained temporary dental prostheses placed on endosseous dental implants in the maxilla and mandible, for up to 180 days. Temporary Abutment Non-Engaging CC are indicated for use with multiple unit screw-retained temporary dental prosthesis placed on endosseous dental implant in the maxilla and mandible, for up to 180 days. | Are indicated for use with single unit screw-retained temporary dental prostheses placed on endosseous dental implants in the maxilla and mandible, for up to 180 days. | Temporary Abutment Non-Engaging is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. Temporary Abutment Non-Engaging Titanium is indicated for screw-retained multiple temporary restorations, for implants with less than 40° overall divergences to allow path of insertion. | Same indications use, differing only in the choice of words | | Clinical setting | The finalized abutment is used in a dental practice | The finalized abutment is used in a dental practice | The finalized abutment is used in a dental practice | Same as Predicate Device (Reference Device #5) | | Primary User Population | Dental healthcare professionals | Dental healthcare professionals | Dental healthcare professionals | Same as Predicate Device (Reference Device #5) | | Patient Population | Patients Subject to dental implant treatment | Patients Subject to dental implant treatment | Patients Subject to dental implant treatment | Same as Predicate Device (Reference Device #5) | | Anatomical Site | Oral cavity | Oral cavity | Oral cavity | Same as Predicate Device (Reference Device #5) | | Technological Characteristics | | | | | | Device Dimensions/ Design Specifications | | | | | | Minimum gingiva height: | 1.5 mm | 1.5 – 3 mm | 1.5 mm 3.0 mm | Same as Predicate Device (Reference Device #5) | | Diameter: | NP Ø 4.1mm RP Ø 4.3mm / Ø 4.8 WP Ø 4.8mm | 3.4 mm 3.7 mm | NP Ø 4.0mm RP Ø 4.5mm WP Ø 6.0mm | In range of Predicate Device (Reference Device #5) and Reference Device #6 | | Screw Channel | straight | straight | straight | Same as Predicate Device (Reference Device #5) | | Abutment Shape | Standardized | Standardized | Standardized | Same as Predicate Device (Reference Device #5) | | Platform compatibility | Narrow Platform (NP) | Narrow Platform (NP) | Narrow Platform (NP) | Same as Predicate Device (Reference Device #5) | {34} N Nobel Biocare™ | Characteristic | Subject Device | Predicate Device (Reference Device #5) | Reference Device #6 | Comparison: | | --- | --- | --- | --- | --- | | | Temporary Abutments Engaging and Non-Engaging Conical Connection | Temporary Abutment Nobel Biocare N1™ TCC | Temporary Snap Abutment (Engaging and Non-Engaging) | | | | | K211109 | K161435 | | | | Regular Platform (RP) | Regular Platform (RP) | Regular Platform (RP) | Same as Predicate Device (Reference Device #5) | | | Wide Platform (WP) | N/A | Wide Platform (WP) | Same as Predicate Device (Reference Device #6) | | Connection interface | Conical Connection | Nobel Biocare Tri-oval Conical Connection | Hexagonal Snap into Conical Connection | Similar as Reference Device #6. The connection interface has the same function as the connection of Predicate Device (Reference Device #5) | | Attachment method to implant | Screw retained | Screw retained | Screw retained | Same as Predicate Device (Reference Device #5) | | Restoration type | single-unit (engaging) multi-unit (non-engaging) | single-unit (non-engaging) | single-unit (engaging) multi-unit (non-engaging) | Same as Reference Device #6 | | Design features | Temporary Abutment fixed onto an implant with a clinical screw Single and Multi-unit | Temporary Abutment fixed onto an implant with a clinical screw Single-unit | Temporary Abutment fixed onto an implant with a clinical screw Single and Multi-unit | Same as Reference Device #6 | | Principle of operation/ Mechanism of action | Mechanical screw connection | Mechanical screw connection | Mechanical screw connection | Same as Predicate Device (Reference Device #5) | | Maximum abutment angulation | 0° | 0° | 0° | Same as Predicate Device (Reference Device #5) | | Material Temporary Abutment | Titanium aluminum vanadium alloy | Titanium aluminum vanadium alloy | Titanium aluminum vanadium alloy | Same as Predicate Device (Reference Device #5) | | | Ti6Al4V ELI (ISO 5832-3, ASTM F136) MTA005 | Ti6Al4V ELI (ISO 5832-3, ASTM F136) MTA005 | Ti6Al4V ELI (ISO 5832-3, ASTM F136) MTA005 | Same as Predicate Device (Reference Device #5) | | Surface treatment | Anodized | Anodized | Anodized (top part) | Same as Predicate Device (Reference Device #5) | | Biocompatibility | biocompatible according to ISO 10993-1 | biocompatible according to ISO 10993-1 | biocompatible according to ISO 10993-1 | Same as Predicate Device (Reference Device #5) | | Tissue contact | Permanent contact with bone and soft tissue | Permanent contact with bone and soft tissue | Permanent contact with bone and soft tissue | Same as Predicate Device (Reference Device #5) | | Shelf life | 5 years | 5 years | N/A – Delivered non-sterile | Same as Predicate Device (Reference Device #5) | {35} N Nobel Biocare™ | Characteristic | Subject Device | Predicate Device (Reference Device #5) | Reference Device #6 | Comparison: | | --- | --- | --- | --- | --- | | | Temporary Abutments Engaging and Non-Engaging Conical Connection | Temporary Abutment Nobel Biocare N1™ TCC | Temporary Snap Abutment (Engaging and Non-Engaging) | | | | | K211109 | K161435 | | | Sterility | Provided Sterile – Gamma R…