IPD Dental Implant Abutments

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Implant Protesis Dental 2004, S.L Francesc Fumanal Regulatory Affairs Manager Carrer Rosa dels Vents, 9-15 Premià de Dalt, Barcelona, 08338 SPAIN June 7, 2024 Re: K240570 Trade/Device Name: IPD Dental Implant Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA. PNP Dated: May 10, 2024 Received: May 10, 2024 Dear Francesc Fumanal: 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. 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. {1}------------------------------------------------ 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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (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. 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. {2}------------------------------------------------ 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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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 Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) # K240570 Device Name IPD Dental Implant Abutments Indications for Use (Describe) IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations. | | Compatible Implant Systems | | |---------------------------------------------------------|------------------------------------|---------------------------------------------------| | Compatible Implant System | Implant Diameter (mm) | Platform Diameter | | Astra Tech Implant System<br>(Osseospeed®) | 3.0 // 3.5/4.0 // 4.5/5.0 | 3.0 // 3.5/4.0 // 4.5/5.0 | | OsseoSpeed™ Plus | 3.6 // 4.2 | 3.6 // 4.2 | | BioHorizons Tapered Internal<br>Implant System | 3.0 // 3.4 // 3.8 // 4.6 // 5.8 | 3.0 // 3.0 // 3.5 // 4.5 // 5.7 | | 3i Osseotite® Certain®<br>Dental Implants | 3.25 // 4.0 // 5.0 | 3.4 // 4.1 // 5.0 | | 3i® Osseotite® Dental Implants | 3.25 // 4.0 // 5.0 | 3.4 // 4.1 // 5.0 | | Straumann® BLX Implant System | 3.5 - 4.5 // 5.0 - 6.5 | RB // WB | | Straumann BLX Ø3.5 mm Implants | 3.5 | RB | | Anyone™ Internal Implant System | 3.5-8.0 | RP | | Xpeed AnyRidge Internal<br>Implant System | 3.5-8.0 | RP | | Conical Connection Implants<br>(MIS® C1) | 3.75 // 4.2 | SP // SP | | MIS Internal Hex Dental<br>Implant System (MIS® Seven®) | 3.30 // 3.75 // 4.20 // 5.0 // 6.0 | Narrow // Standard //<br>Standard // Wide // Wide | | Osstem Implant System | 3.0 // 3.5 // 4.0-7.0 | Mini // Mini // Regular | {4}------------------------------------------------ The zirconia superstructures for use with the Ti Base (Interface) are only intended to be designed and manufactured according to digital dentistry 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. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ # 510(k) SUMMARY # I. SUBMITTER # IMPLANT PROTESIS DENTAL 2004, S.L Carrer Rosa dels Vents, 9-15 08338 Premià de Dalt (Barcelona), Spain. # Contact Person: Francesc Fumanal +34 93 278 84 91 ffumanal@jpd2004.com Date prepared: June 7, 2024. # II. DEVICE | Device name: | IPD DENTAL IMPLANT ABUTMENTS | |----------------------|------------------------------------------------------| | Common Name: | ENDOSSEOUS DENTAL IMPLANT ABUTMENT | | Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) | | Regulatory Class: | Class II | | Product Code(s): | Primary: NHA; Secondary: PNP. | # III. PREDICATE DEVICE(S): | Primary Predicate: | K231413, IPD Dental Implant Abutments | |--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------| | Reference Devices: | K222288, DESS Dental Smart Solutions | | | The list of all the proposed third-party compatible dental implant systems, as additional Reference Devices, has been provided in <b>Table 1</b> . | Table 1. Reference Devices - Compatible Dental Implant Systems: | 510(k) Holder | Compatible Implant System | 510(k) Number | 510(k) Device Name | |--------------------------------------|------------------------------------------------|---------------|------------------------------------------------| | Astra Tech AB | Astra Tech Implant System<br>(Osseospeed®) | K101732 | Astra Tech Implant System<br>(Osseospeed®) | | Astra Tech AB | OsseoSpeed™ Plus | K120414 | OsseoSpeed™ Plus | | Biohorizons Implant<br>Systems, Inc. | BioHorizons Tapered Internal Implant<br>System | K071638 | BioHorizons Tapered Internal<br>Implant System | | Implant Innovations,<br>Inc. | 3i Osseotite® Certain® Dental<br>Implants | K063341 | 3i Osseotite® Certain®<br>Dental Implants | | Implant Innovations,<br>Inc. | 3i® Osseotite® Dental Implants | K063286 | 3i OSSEOTITE® Dental<br>Implants | | Institut Straumann AG | Straumann® BLX Implant System | K173961 | Straumann® BLX Implant<br>System | | Institut Straumann AG | Straumann BLX Ø3.5 mm Implants | K191256 | Straumann BLX Ø3.5 mm<br>Implants | | MegaGen Implant<br>Co., Ltd | Anyone™ Internal Implant System | K123988 | Anyone™ Internal Implant<br>System | {6}------------------------------------------------ Administrative Information - 510(k) Summary | 510(k) Holder | Compatible Implant System | 510(k) Number | 510(k) Device Name | |-----------------------------------|---------------------------------------------------------|---------------|-------------------------------------------| | MegaGen Implant<br>Co., Ltd | Xpeed AnyRidge Internal Implant<br>System | K140091 | Xpeed AnyRidge Internal<br>Implant System | | MIS Implants<br>Technologies Ltd. | Conical Connection Implants<br>(MIS® C1) | K112162 | Conical Connection Implants | | MIS Implants<br>Technologies Ltd. | MIS Internal Hex Dental Implant<br>System (MIS® Seven®) | K180282 | MIS Internal Hex Dental<br>Implant System | | OSSTEM Implant<br>Co., Ltd. | Osstem Implant System | K161604 | Osstem Implant System | # IV. DEVICE DESCRIPTION IPD Dental Implant Abutments is a dental implant abutment system composed of dental abutments and screws intended to be placed into dental implants to provide support for dental prosthetic restorations. Abutments provide basis for single or multiple tooth prosthetic restorations. They are available in a variety of connection types to enable compatibility with commercially available dental implants systems. IPD Dental Implant Abutments includes the following categories of dental abutment designs: - -Healing abutments; - Temporary abutments; - - -Cementing titanium abutments; - -Titanium base (interface) abutments; The system also includes the corresponding Titanium Screws intended to attach the prosthesis to the dental implant. Specifically: - Ti Screw: Used during restoration fabrication. - TiN Screw: Used in finished restorations, with TiN coating. - TPA Screw: Used in finished angulated restorations, with TiN coating. The metallic components of the subject abutments and screws are made of titanium alloy conforming to ISO 5832-3 "Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium allov". The purpose of this submission is to expand IPD Dental Implant Abutments cleared under K231413 to: - Include new OEM dental implant platform compatibilities (previously not cleared) for . previously cleared IPD's abutment designs. IPD dental implant abutments and screws are compatible with the following commercially available dental implant systems: {7}------------------------------------------------ | Compatible Implant System | Type of<br>connection | Implant<br>Diameter (mm) | Platform<br>Diameter | Device category<br>Material<br>IPD Abutment<br>Systems | Healing<br>Abutment<br>Titanium alloy,<br>ISO 5832-3 | Cementing /<br>Temporary<br>Abutments<br>Titanium alloy, ISO<br>5832-3<br>Temp. Anodized | Ti Base (Interface)<br>Abutment<br>Titanium alloy, ISO<br>5832-3<br>TiN coated | | |---------------------------------------------------------|-----------------------|------------------------------------|------------------------------------------------|--------------------------------------------------------|------------------------------------------------------|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------| | Osstem Implant System | Internal | 3.0<br>3.5<br>4.0 - 7.0 | Mini<br>Mini<br>Regular | OB | Mini<br>Mini<br>Regular | Mini<br>Mini<br>Regular | Mini (0°)<br>Mini (0°)<br>Regular (30°) | | | Anyone™ Internal Implant System | Internal | 3.5 -8.0 | RP | WA | RP | RP | RP (30°) | | | Xpeed AnyRidge Internal Implant<br>System | Internal | 3.5 -8.0 | RP | WB | RP | RP | RP (0°) | | | 3i® Osseotite® Dental Implants | External | 3.25<br>4.0<br>5.0 | 3.4<br>4.1<br>5.0 | BA | 3.4<br>4.1<br>5.0 | 3.4<br>4.1<br>5.0 | 3.4 (0°)<br>4.1 (0°)<br>5.0 (0°) | | | 3i Osseotite® Certain® Dental<br>Implants | Internal | 3.25<br>4.0<br>5.0 | 3.4<br>4.1<br>5.0 | BB | 3.4<br>4.1<br>5.0 | 3.4<br>4.1<br>5.0 | 3.4 (0°)<br>4.1 (0°)<br>5.0 (0°) | | | Astra Tech Implant System<br>(Osseospeed®) | Internal | 3.0<br>3.5/4.0<br>4.5/5.0 | 3.0<br>3.5/4.0<br>4.5/5.0 | EA | 3.0<br>3.5/4.0<br>4.5/5.0 | 3.0<br>3.5/4.0<br>4.5/5.0 | 3.0 (0°)<br>3.5/4.0 (30°)<br>4.5/5.0 (30°) | | | OsseoSpeed™ Plus | Internal | 3.6<br>4.2 | 3.6<br>4.2 | EB | 3.6<br>4.2 | 3.6<br>4.2 | 3.6 (0°)<br>4.2 (0°) | | | BioHorizons Tapered Internal<br>Implant System | Internal | 3.0<br>3.4<br>3.8<br>4.6<br>5.8 | 3.0<br>3.0<br>3.5<br>4.5<br>5.7 | LB | 3.0<br>3.0<br>3.5<br>4.5<br>5.7 | 3.0<br>3.0<br>3.5<br>4.5<br>5.7 | 3.0 (0°)<br>3.0 (0°)<br>3.5 (30°)<br>4.5 (30°)<br>5.7 (30°) | | | MIS Internal Hex Dental Implant<br>System (MIS® Seven®) | Internal | 3.30<br>3.75<br>4.20<br>5.0<br>6.0 | Narrow<br>Standard<br>Standard<br>Wide<br>Wide | TA | Narrow<br>Standard<br>Standard<br>Wide<br>Wide | Narrow<br>Standard<br>Standard<br>Wide<br>Wide | Narrow (0°)<br>Standard (30°)<br>Standard (30°)<br>Wide (30°)<br>Wide (30°) | | | Conical Connection Implants | Internal | 3.75 | SP | TB | SP | SP | SP (30°) | | | Compatible Implant System | Type of<br>connection | Implant<br>Diameter (mm) | Platform<br>Diameter | Device category | | Healing<br>Abutment | Cementing /<br>Temporary<br>Abutments | Ti Base (Interface)<br>Abutment | | | | | | Material | IPD Abutment<br>Systems | Titanium alloy,<br>ISO 5832-3 | Titanium alloy, ISO<br>5832-3<br>Temp. Anodized | Titanium alloy, ISO<br>5832-3<br>TiN coated | | (MIS® C1) | | 4.2 | SP | | | SP | SP | SP (30°) | | Straumann BLX Ø3.5 mm Implants | | 3.5 | RB | | | RB | RB | RB (0°) | | Straumann® BLX Implant System | Internal | 3.5 - 4.5 | RB | DC | | RB | RB | RB (0°) | | Straumann® BLX Implant System | | 5.0 - 6.5 | WB | | | WB | WB | WB (0°) | Table 2. Summary of IPD abutments categories with compatibilized OEM Implant Systems to maximum angulation: {8}------------------------------------------------ {9}------------------------------------------------ Ti Base (Interface) abutments are used as an interface between the dental implant and the zirconia superstructure. They are attached (screw-retained) to the implant and cemented to the zirconia superstructure. The Ti Base (Interface) is a two-piece abutment composed of the Ti Base (Interface) as the bottomhalf and the zirconia superstructure as the top-half. It consists of a pre-manufactured prosthetic component in Titanium alloy per ISO 5832-3, as well as the supporting digital library file for FDAcleared design software (e.g., 3Shape Abutment Designer™ Software, cleared under K151455) which enables the design of a patient-specific superstructure by the laboratory/clinician and which will be manufactured in FDA-cleared Zirconia (e.g., DD Bio Z, K142987) according to digital dentistry workflow at the point of care, or at a dental laboratory. The design and fabrication of the zirconia superstructure for Ti Bases (Interfaces) will be conducted using a digital dentistry workflow requiring the use of the following equipment: Scanner: 3D Scanner D850. Design Software: 3Shape Abutment Designer Software, K151455. Zirconia Material: DD Bio Z, K142987. Milling machine: Brand: Dental Concept System Model: DC1 Milling System. Cement: Multilink® Automix, K123397. Ti Base (Interface) abutments design parameters for the zirconia superstructure are defined as follows: | Minimum gingival height: | 1.5 mm | |---------------------------------------------------|-------------| | Minimum wall thickness: | 0.43 mm | | Minimum post height for single-unit restorations: | 4.75 mm (1) | | Maximum gingival height: | 6.0 mm | | Maximum angulation of the final abutment | 30° (2) | Note 1: Post height is the length above the abutment collar. Note 2: in Table 2 it has been specifically referred the angulation depending on the dental implant system and platform. The laboratory designed superstructure is attached to Ti Base (Interface) by the use of an FDA-cleared cement (e.g., Multilink® Automix, K123397). The resulting final prosthetic restoration is screwed to the dental implant. All subject abutments are single-use and provided non-sterile. Final restoration (which includes the corresponding screw) is intended to be sterilized at the dental clinic before it is placed in the patient. {10}------------------------------------------------ # V. INDICATIONS FOR USE IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations. | Compatible Implant System | Implant Diameter (mm) | Platform Diameter | |---------------------------------------------------------|-----------------------|-------------------| | Astra Tech Implant System<br>(Osseospeed®) | 3.0 | 3.0 | | | 3.5/4.0 | 3.5/4.0 | | | 4.5/5.0 | 4.5/5.0 | | OsseoSpeed™ Plus | 3.6 | 3.6 | | | 4.2 | 4.2 | | BioHorizons Tapered Internal Implant<br>System | 3.0 | 3.0 | | | 3.4 | 3.0 | | | 3.8 | 3.5 | | | 4.6 | 4.5 | | | 5.8 | 5.7 | | 3i Osseotite® Certain® Dental Implants | 3.25 | 3.4 | | | 4.0 | 4.1 | | | 5.0 | 5.0 | | 3i® Osseotite® Dental Implants | 3.25 | 3.4 | | | 4.0 | 4.1 | | | 5.0 | 5.0 | | Straumann® BLX Implant System | 3.5 - 4.5 | RB | | | 5.0 - 6.5 | WB | | Straumann BLX Ø3.5 mm Implants | 3.5 | RB | | Anyone™ Internal Implant System | 3.5 -8.0 | RP | | Xpeed AnyRidge Internal Implant System | 3.5 -8.0 | RP | | Conical Connection Implants<br>(MIS® C1) | 3.75 | SP | | | 4.2 | SP | | MIS Internal Hex Dental Implant System<br>(MIS® Seven®) | 3.30 | Narrow | | | 3.75 | Standard | | | 4.20 | Standard | | | 5.0 | Wide | | | 6.0 | Wide | | Osstem Implant System | 3.0 | Mini | | | 3.5 | Mini | | | 4.0 - 7.0 | Regular | Compatible Implant Systems The zirconia superstructures for use with the Ti Base (Interface) are only intended to be designed and manufactured according to digital dentistry 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. {11}------------------------------------------------ #### OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. COMPARISON PREDICATE DEVICE The subject device is substantially equivalent in indications and design principles to the primary predicate device. Comparative tables of indications for use and relevant technological characteristics have been provided as follows. Table 3. Indications for Use Statements. | Indications for Use Statements | | | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------| | Subject device | | | | IPD Dental<br>Implant<br>Abutments | IPD Dental Implant Abutments are intended to be used in conjunction with endosseous<br>dental implants in the maxillary or mandibular arch to provide support for single or multiple | | | (Implant<br>Protesis | dental prosthetic restorations. | | | Dental 2004,<br>SL) | Compatible Implant Systems | | | | Dental Implant System | Implant Diameter<br>(mm) Platform Diameter | | | Astra Tech Implant System<br>(Osseospeed®) | 3.0 3.0 | | | | 3.5/4.0 3.5/4.0 | | | | 4.5/5.0 4.5/5.0 | | | OsseoSpeed™ Plus | 3.6 3.6 | | | | 4.2 4.2 | | | BioHorizons Tapered Internal<br>Implant System | 3.0 3.0 | | | | 3.4 3.0 | | | | 3.8 3.5 | | | | 4.6 4.5 | | | | 5.8 5.7 | | | 3i Osseotite® Certain® Dental<br>Implants | 3.25 3.4 | | | | 4.0 4.1 | | | | 5.0 5.0 | | | 3i® Osseotite® Dental Implants | 3.25 3.4 | | | | 4.0 4.1 | | | | 5.0 5.0 | | | Straumann® BLX Implant<br>System | 3.5 - 4.5 RB | | | | 5.0 - 6.5 WB | | | Straumann BLX Ø3.5 mm<br>Implants | 3.5 RB | | | Anyone™ Internal Implant<br>System | 3.5 -8.0 RP | | | Xpeed AnyRidge Internal<br>Implant System | 3.5 -8.0 RP | | | Conical Connection Implants<br>(MIS® C1) | 3.75 SP | | | | 4.2 SP | | | MIS Internal Hex Dental Implant<br>System (MIS® Seven®) | 3.30 Narrow | | | | 3.75 Standard | {12}------------------------------------------------ | | | | 4.20 | | Standard | | |----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|----------------------------|--|-----------------------|--| | | | | 5.0 | | Wide | | | | | 6.0 | | | Wide | | | | | | 3.0 | | Mini | | | | Osstem Implant System | | 3.5 | | Mini | | | | | | 4.0 - 7.0 | | Regular | | | | | | | | | | | | The zirconia superstructures for use with the Ti Base (Interface) are only intended to be<br>designed and manufactured according to digital dentistry workflow. The workflow system<br>integrates multiple components of the digital dentistry workflow: scan files from intra-<br>oral scanners, CAD software, CAM software, ceramic material, milling machine and<br>associated tooling and accessories. | | | | | | | Predicate Devices | | | | | | | | Primary Predicate Device | | | | | | | | K231413 | IPD Dental Implant Abutments are intended to be used in conjunction with endosseous<br>dental implants in the maxillary or mandibular arch to provide support for single or | | | | | | | IPD Dental<br>Implant | multiple dental prosthetic restorations. | | | | | | | Abutments | | | Compatible Implant Systems | | | | | (Implant | | | | | | | | Protesis<br>Dental 2004, | Implant System<br>Compatibility | | Implant Diameter (mm) | | Platform Diameter | | | SL) | | | 3.0 | | 3.0 mm | | | | NobelActive® | | 3.5 | | NP (3.5 mm) | | | | | | 4.3/5.0 | | RP (4.3 mm) | | | | | | 3.3 | | NC (3.3 mm) | | | | Straumann® Bone Level | | 4.1/4.8 | | RC (4.1 mm) | | | | Neodent Implant System<br>– GM Line | | 3.5 - 7.0 | | GM (Grand Morse) | | | | | | 3.7 / 4.1 | | 3.5 mm | | | | Tapered Screw-Vent® | | 4.7 | | 4.5 mm | | | | | | 6.0 | | 5.7 mm | | | | The zirconia superstructures for use with the Ti Base (Interface) are only intended to be<br>designed and manufactured according to digital dentistry workflow. The workflow system<br>integrates multiple components of the digital dentistry workflow: scan files from intra-<br>oral scanners, CAD software, CAM software, ceramic material, milling machine and<br>associated tooling and accessories. | | | | | | | Reference Device | | | | | | | | K222288<br>DESS Dental<br>Smart<br>Solutions | DESS Dental Smart Solutions abutments are intended to be used in conjunction with<br>endosseous dental implants in the maxillary or mandibular arch to provide support for<br>prosthetic restorations. | | | | | | | (Terrats<br>Medical, SL) | All digitally designed custom abutments for use with Ti Base abutments or Pre-milled<br>Blank abutments are to be sent to a Terrats Medical validated milling center for<br>manufacture. | | | | | | | | Compatible Implant System | | Implant Body Diameter, mm | | Implant Platform Name | | | | Ankylos C/X | | 3.5, 4.5, 5.5 | | 2.52 | | | | Astra Tech EV | | 3.0 | | 3.0 | | | | | | 3.6 | | 3.6 | | {13}------------------------------------------------ | | 4.2 | 4.2 | | |-----------------------------|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------| | | 4.8 | 4.8 | | | | 5.4 | 5.4 | | | | 3.0 | 3.0 | | | Astra Tech OsseoSpeed™ | 3.5/4.0 | 3.5/4.0 | | | | 4.5/5.0 | 4.5/5.0 | | | | 3.0, 3.4, 3.8 | 3.0 | | | | 3.8, 4.6 | 3.5 | | | BioHorizons | 4.6, 5.8 | 4.5 | | | | 5.8 | 5.7 | | | | 3.25 | 3.4 | | | Biomet 3i Certain® | 4.0 | 4.1 | | | | 5.0 | 5.0 | | | | 3.25 | 3.4 | | | Biomet 3i OSSEOTITE® | 3.75, 4.0 | 4.1 | | | | 5.0 | 5.0 | | | | 3.8 | 3.8 | | | Camlog | 4.3 | 4.3 | | | | 5.0 | 5.0 | | | Dentium SuperLine | 3.6, 4.0, 4.5, 5.0, 6.0, 7.0 | 3.3 | | | | 3.4 | 3.4 | | | | 3.8 | 3.8 | | | FRIADENT XIVE® | 4.5 | 4.5 | | | | 5.5 | 5.5 | | | MegaGen AnyRidge | 3.5, 4.0, 4.5, 5.0, 5.5 | 3.5 | | | Neodent Grand Morse | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | Grand Morse (GM) | | | NobelActive®, NobelParallel | 3.0 | 3.0 | | | | 3.5 | NP | | | Conical | 4.3, 5.0 | RP | | | | 3.5 | NP | | | | 4.3 | RP | | | NobelReplace® Trilobe | 5.0 | WP | | | | 6.0 | 6.0 | | | | 3.3 | NP | | | Nobel Brånemark System® | 3.75, 4.0 | RP | | | | 5.0 | WP | | | Osstem TS | 3.5 | Mini | | | | 4.0, 4.5, 5.0, 6.0, 7.0 | Regular | | | Straumann BLX | 3.5, 3.75, 4.0, 4.5 | RB | | | | 5.0, 5.5, 6.5 | WB | | | Straumann® Bone Level | 3.3 | NC | | | | 4.1/4.8 | RC | | | | 3.3 | NNC, RN | | | Straumann® Tissue Level | 4.1 | RN | | | | 4.8 | RN, WN | | | Zimmer Eztetic | 3.1 | 2.9 | | | | 3.3, 3.7, 4.1 | 3.5 | | | Zimmer Screw Vent®/ | 4.7 | 4.5 | | | Tapered Screw- Vent® | 6.0 | 5.7 | | | | 3.25 | 3.25 | | | Zimmer Spline | 3.75, 4.0 | 3.75/4.0 | | | | 5.0 | 5.0 | | | | Zimmer SwissPlus | . Children Children Children Children Children Children Children Children Children Children Children Children Children Suite Station Schward Schward Station | رات ل | | | | | | {14}------------------------------------------------ Administrative Information - 510(k) Summary #### Discussion on Indications for Use: The indications for use of subject device in comparison with primary predicate device are verbatim, with the exception of the new implant systems which IPD is claiming compatibility for this submission. Further than this, no change in the intended use or indications for use of the IPD Dental Implant Abutments has been carried out. The devices are specifically indicated for patients undergoing oral implant surgery to provide support for dental prosthetic restorations. Similarly, for the subject device and primary predicate device, the design and fabrication of the superstructure is conducted using the same digital dentistry workflow, requiring the use of the following equipment: | Scanner: | 3Shape scanner | |--------------------|---------------------------------------------| | Design Software: | 3Shape Abutment Designer Software (K151455) | | Zirconia Material: | DD Bio Z (K142987) | | Milling machine: | Dental Concept System DC1 Milling System | | Cement: | Multilink® Automix (K123397) | and using the supporting IPD digital library file for K151455. The adequacy of the digital dentistry workflow for the subject device is substantiated by software validation and mechanical fatigue testing provided with the submission. As previously referred, differences may be found in the list of compatible implant systems for subject and predicate devices. Compatibility of the subject abutments with the specific OEM implants is based on engineering and dimensional analysis, as well as mechanical fatigue testing. In that sense, reference device, K222288, has been selected for the range of compatibility implant systems which encompasses (not exhaustive list) and which IPD is also citing compatibility. Similarly, the whole set of compatible dental implant systems and their respective 510(k) have been also included in this submission as reference devices. Despite this, no further differences are found in the device categories included for subject and predicate devices, and same approach is followed for finalizing the zirconia superstructures. It is IPD opinion that these differences do not affect the intended use of the subject device, and/or do not raise differences in terms of safety or efficacy. {15}------------------------------------------------ | Characteristics | Subject Device<br>IPD Dental Implant<br>Abutments | Primary Predicate<br>Device<br>IPD Dental Implant<br>Abutments<br>(IPD) K231413 | Reference Device<br>DESS Dental Smart<br>Solutions<br>(Terrats Medical, SL)<br>K222288 | |-------------------------------------------------|--------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------| | Materials | | | | | Abutment Materials | Titanium Alloy Grade 5<br>(ISO 5832-3) + TiN or<br>Anodized (TiO2) | Titanium Alloy Grade 5<br>(ISO 5832-3) + TiN or<br>Anodized (TiO2) | Ti-6Al-4V ELI + ZrN<br>Coating | | Screw Materials | Titanium Alloy Grade 5<br>(ISO 5832-3) + TiN | Titanium Alloy Grade 5<br>(ISO 5832-3) + TiN | Ti-6Al-4V ELI +<br>DLC Coating | | Superstructure | DD Bio Z Zirconia<br>(K142987) | DD Bio Z Zirconia<br>(K142987) | Zirconia conforming ISO<br>13356 | | General Design Features | | | | | Overview of<br>abutment designs | Healing,<br>Temporary,<br>Cementing,<br>Ti-Base (Interface) | Healing,<br>Temporary,<br>Cementing,<br>Ti-Base (Interface) | Healing, Temporary<br>Abutment, Ti Base, C-<br>base, CrCo Base,<br>Premilled Blank, Multi<br>Unit Abutment, Multi<br>Unit ZRN Abutment,<br>DESSLoc | | Prosthesis<br>Attachment | Cement-retained<br>Screw-retained | Cement-retained<br>Screw-retained | Cement-retained<br>Screw-retained | | Restoration Type | Single-unit (crowns)<br>Multiple-unit (bridges) | Single-unit (crowns)<br>Multiple-unit (bridges) | Single-unit,<br>Multi-unit | | Abutment / Implant<br>Platform Diameter<br>(mm) | 3.0 - 5.7 | 3.0 - 5.7 | 2.52 - 6.5 | | Abutment Angle | Maximum: 30° | Maximum: 30° | 0°, 17°, 30° | | General Abutment /<br>Implant Connection | Internal and External | Internal and External | Internal and External | | Sterilization | | | | | Sterilization status<br>and type | Non-sterile.<br>End user steam<br>sterilization | Non-sterile.<br>End user steam<br>sterilization | Non-sterile.<br>End user steam<br>sterilization | | Tables 4. Subject and Predicate devices technological characteristics comparison. | | |-----------------------------------------------------------------------------------|--| |-----------------------------------------------------------------------------------|--| | Healing Abutments | | | | |------------------------------|-----------------------|-------------------------------------------|------------------------------------------| | Characteristics…