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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below. Implant Protesis Dental 2004, S.L. Francesc Fumanal Regulatory Affairs Manager Cami del Mig. 71. 1º 2º Mataro, Barcelona 08302 SPAIN # Re: K231413 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: September 6, 2023 Received: September 6, 2023 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}------------------------------------------------ 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 510(k) Number (if known) K231413 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. | Implant System Compatibility | Implant Diameter (mm) | Platform Diameter | |----------------------------------|-----------------------|-------------------| | NobelActive® | 3.0 | 3.0 mm | | NobelActive® | 3.5 | NP (3.5 mm) | | NobelActive® | 4.3/5.0 | RP (4.3 mm) | | Straumann® Bone Level | 3.3 | NC (3.3 mm) | | Straumann® Bone Level | 4.1/4.8 | RC (4.1 mm) | | Neodent Implant System – GM Line | 3.5 - 7.0 | GM (Grand Morse) | | Tapered Screw-Vent® | 3.7 / 4.1 | 3.5 mm | | Tapered Screw-Vent® | 4.7 | 4.5 mm | | Tapered Screw-Vent® | 6.0 | 5.7 mm | #### 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. The workflow system integrates multiple components of the digital dentistry workflow: scan files from intra-oral scanners, CAD software, ceramic material, milling machine and associated tooling and accessories. | Type of Use ( <i>Select one or both, as applicable</i> ) | | |----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | <div> <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | 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 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." {4}------------------------------------------------ # 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 93 672 110 748 ffumanal@ipd2004.com Date prepared: October 10th, 2023. #### 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: | K222215, IPD Dental Implant Abutments | |--------------------|---------------------------------------| | Reference Device: | K222288, DESS Dental Smart Solutions | | Clearance | Device | Manufacturer | |-----------|----------------------------------|--------------------------------------------------------| | K142260 | Nobel Active® | Nobel Biocare AB | | K140878 | Straumann® Bone Level | Institut Straumann AG | | K163194 | Neodent Implant System – GM Line | JJGC Indústria e Comércio de<br>Materiais Dentários SA | | K112160 | Tapered Screw-Vent® | Zimmer Biomet Dental | {5}------------------------------------------------ #### 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 submission 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. All 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 alloy". The purpose of this submission is to expand IPD Dental Implant Abutments cleared under K222215 to: - . Include new OEM dental implant platform compatibilities (previously not cleared) for previously cleared IPD's abutment designs, - . include previously-cleared OEM platform compatibilities for previously-cleared IPD's abutment designs for which the specific combinations of compatibility and design were not cleared previously, and, - Add angulation to previously Ti Base (Interface) abutments (design parameters for the ● zirconia superstructure). IPD dental implant abutments and screws are compatible with the following commercially available dental implant systems: {6}------------------------------------------------ | Compatible<br>Implant<br>System | Type of<br>connection | Implant<br>Diameter<br>(mm) | Platform<br>Diameter | Device<br>category | Healing<br>Abutment | Cementing<br>/<br>Temporary<br>Abutments | Ti Base<br>(Interface)<br>Abutment | |-------------------------------------------|-----------------------|-----------------------------|--------------------------------------|----------------------------|----------------------------------|------------------------------------------|----------------------------------------------| | | | | | Material | | Titanium<br>alloy, ISO 5832-3 | Titanium<br>alloy, ISO 5832-3,<br>TiN coated | | | | | | IPD<br>Abutment<br>Systems | Titanium<br>alloy, ISO<br>5832-3 | 3,<br>Temp.<br>Anodized | | | Nobel<br>Active® | Internal | 3.0<br>3.5<br>4.3/5.0 | 3.0 mm<br>NP (3.5 mm)<br>RP (4.3 mm) | AD | 3.0<br>3.5<br>4.3 | 3.0<br>3.5<br>4.3 | 3.0<br>3.5<br>4.3 | | Straumann®<br>Bone Level | Internal | 3.3<br>4.1/4.8 | NC (3.3 mm)<br>RC (4.1 mm) | DB | 3.3<br>4.1 | 3.3<br>4.1 | 3.3<br>4.1 | | Neodent<br>Implant<br>System – GM<br>Line | Internal | 3.5 – 7.0 | GM<br>(Grand<br>Morse) | RB | GM | GM | GM | | Tapered<br>Screw-Vent® | Internal | 3.7 / 4.1<br>4.7<br>6.0 | 3.5 mm<br>4.5 mm<br>5.7 mm | FA | *<br>*<br>5.7 | *<br>* | *<br>* | Table 5.1. Summary of IPD abutments categories with compatibilized OEM Implant Systems. (*) Previously cleared under K222215. The abovementioned Compatible Implant Systems received FDA-clearance with the following 510(k) concurrence numbers: Nobel Active® K142260; Straumann® Bone Level Tapered Implants K140878, Neodent Implant System - GM Line K163194, and Tapered Screw-Vent K113756 (aka Tapered Screw-Vent® X Implant). 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. {7}------------------------------------------------ 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 wall thickness: | 0.43 mm | |---------------------------------------------------|---------| | Minimum post height for single-unit restorations: | 4.75 mm | | Maximum gingival height: | 6.0 mm | | Minimum gingival height: | 1.5 mm | | Maximum angulation of the final abutment1 | 30° | 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. # 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. | Implant System Compatibility | Implant Diameter (mm) | Platform Diameter | |------------------------------|----------------------------------|-------------------| | NobelActive® | 3.0 | 3.0 mm | | NobelActive® | 3.5 | NP (3.5 mm) | | | 4.3/5.0 | RP (4.3 mm) | | Straumann® Bone Level | 3.3 | NC (3.3 mm) | | Straumann® Bone Level | 4.1/4.8 | RC (4.1 mm) | | | Neodent Implant System – GM Line | 3.5 – 7.0 | | Tapered Screw-Vent® | 3.7 / 4.1 | 3.5 mm | | | 4.7 | 4.5 mm | | | 6.0 | 5.7 mm | #### 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. ¹ With the exception of Nobel Active® 3.0 and 3.5 mm-platforms which final abutment is straight (0°). {8}------------------------------------------------ #### TECHNOLOGICAL CHARACTERISTICS WITH THE VI. COMPARISON OF 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 in the following pages. ## Table 5.2. Indications for Use Statements. | Indications for Use Statements | | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|-------------------------------------------| | Subject device | 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. | | | | IPD Dental<br>Implant<br>Abutments<br>(Implant<br>Protesis Dental<br>2004, SL) | Compatible Implant Systems | | | | | Implant System Compatibility | Implant Diameter (mm) | Platform Diameter | | | NobelActive® | 3.0<br>3.5<br>4.3/5.0 | 3.0 mm<br>NP (3.5 mm)<br>RP (4.3 mm) | | | Straumann® Bone Level | 3.3<br>4.1/4.8 | NC (3.3 mm)<br>RC (4.1 mm) | | | Neodent Implant System – GM Line | 3.5 – 7.0 | GM (Grand Morse) | | | Tapered Screw-Vent® | 3.7 / 4.1<br>4.7<br>6.0 | 3.5 mm<br>4.5 mm<br>5.7 mm | | The zirconia superstructures for use with the Ti Base (Interface) 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. | | | | | Primary Predicate Device | | | | | K222215<br>IPD Dental<br>Implant<br>Abutments<br>(Implant<br>Protesis Dental<br>2004, SL) | 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 | | | | | Implant System Compatibility | Implant Diameter (mm) | Platform Diameter | | | Brånemark | 3.5<br>3.75 / 4.0<br>5.0 | NP (3.5 mm)<br>RP (4.1 mm)<br>WP (5.1 mm) | | | Straumann® Tissue Level | 3.3 / 4.1 / 4.8<br>4.8 | RN (4.8 mm)<br>WN (6.5 mm) | | | Tapered Screw-Vent® | 3.7 / 4.1<br>4.7<br>6.0 | 3.5 mm<br>4.5 mm<br>5.7 mm | | Reference Device | | | | | K222288 | | | | | DESS Dental Smart Solutions | | | | | (Terrats Medical, SL) | | | | | Compatible Implant System | Implant Body Diameter, mm | Implant Platform Name | | | Ankylos C/X | 3.5, 4.5, 5.5 | 2.52 | | | | 3.0 | 3.0 | | | Astra Tech EV | 3.6 | 3.6 | | | | 4.2 | 4.2 | | | | 4.8 | 4.8 | | | | 5.4 | 5.4 | | | Astra Tech OsseoSpeed™ | 3.0 | 3.0 | | | | 3.5/4.0 | 3.5/4.0 | | | | 4.5/5.0 | 4.5/5.0 | | | BioHorizons | 3.0, 3.4, 3.8 | 3.0 | | | | 3.8, 4.6 | 3.5 | | | | 4.6, 5.8 | 4.5 | | | | 5.8 | 5.7 | | | Biomet 3i Certain® | 3.25 | 3.4 | | | | 4.0 | 4.1 | | | | 5.0 | 5.0 | | | Biomet 3i OSSEOTITE® | 3.25 | 3.4 | | | | 3.75, 4.0 | 4.1 | | | | 5.0 | 5.0 | | | Camlog | 3.8 | 3.8 | | | | 4.3 | 4.3 | | | | 5.0 | 5.0 | | | Dentium SuperLine | 3.6, 4.0, 4.5, 5.0, 6.0, 7.0 | 3.3 | | | FRIADENT XiVE® | 3.4 | 3.4 | | | | 3.8 | 3.8 | | | | 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 Conical | 3.0 | 3.0 | | | | 3.5 | NP | | | | 4.3, 5.0 | RP | | | NobelReplace® Trilobe | 3.5 | NP | | | | 4.3 | RP | | | | | | | | | | 6.0 | 6.0 | | | Nobel Brånemark System® | 3.3 | NP | | | | 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 | | | Straumann® Tissue Level | 3.3 | NNC, RN | | | | 4.1 | RN | | | | 4.8 | RN, WN | | | Zimmer Eztetic | 3.1 | 2.9 | | | Zimmer Screw Vent®/<br>Tapered Screw- Vent® | 3.3, 3.7, 4.1 | 3.5 | | | | 4.7 | 4.5 | | | | 6.0 | 5.7 | | | Zimmer Spline | 3.25 | 3.25 | | | | 3.75, 4.0 | 3.75/4.0 | | | | 5.0 | 5.0 | | | Zimmer SwissPlus | 3.7 | 3.8 | | | | 4.8 | 4.8 | {9}------------------------------------------------ {10}------------------------------------------------ #### IPD Dental Implant Abutments Traditional 510(k) #### 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 in this 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 and which IPD is citing compatibility by this submission. {11}------------------------------------------------ Despite this, no differences are found in the device categories included for subject and predicate devices, and same approach is followed for finalizing the zirconia superstructures. Similarly, and thanks to the fatigue testing carried out and provided in this submission, the maximum angulation of the final abutment has been expanded. 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. | Characteristics | Subject Device<br>IPD Dental Implant<br>Abutments | Primary Predicate<br>Device<br>IPD Dental Implant<br>Abutments<br>(IMPLANT PROTESIS<br>DENTAL 2004, S.L.)<br>K222215 | 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 | Titanium Alloy Grade 5<br>(ISO 5832-3) + TiN or<br>Anodized | Ti-6Al-4V ELI | | 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<br>ISO 13356 | | General Design features | | | | | Overview of abutment<br>designs | Healing,<br>Temporary,<br>Cementing Titanium,<br>Titanium interface | Healing,<br>Temporary,<br>Cementing Titanium,<br>Titanium 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 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 (mm) | 3.0 - 5.7 | 3.5 - 6.5 | 2.52 - 6.5 | | Abutment Angle | Abutment: Straight (0°)<br>Superstructure:<br>…