Abutment, Implant, Dental, Endosseous
The Abutment, Implant, Dental, Endosseous (product code NHA) is a dental component that connects to an endosseous dental implant fixture and serves as the structural foundation for a crown, bridge, or denture, as described in its definition. It is classified as an FDA Class 2 device within the Dental specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device carries an implant designation as it is used in conjunction with a surgically placed implant fixture.
Basic Information
- Product Code
- NHA
- Device Class
- FDA class 2
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
Definition
To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 673 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250967 | Sherlock | Jun 26, 2025 | Substantially Equivalent | Open Implants, LLC |
| K243009 | MIST IC | Jun 24, 2025 | Substantially Equivalent | Imagine Milling Technologies, LLC |
| K242978 | Geo Abutment | Jun 16, 2025 | Substantially Equivalent | GeoMedi Co., Ltd. |
| K243530 | Dynamic TiBase | May 30, 2025 | Substantially Equivalent | Talladium España, SL |
| K250614 | Neodent Implant System - Custom Abutments | May 27, 2025 | Substantially Equivalent | JJGC Indústria e Comércia de Materiais Dentários S.A. |
| K250639 | DESS Dental Smart Solutions | May 22, 2025 | Substantially Equivalent | Terrats Medical SL |
| K243824 | Preat Abutments | May 08, 2025 | Substantially Equivalent | Preat Corporation |
| K243521 | Conical Ti Base abutments | May 01, 2025 | Substantially Equivalent | BioHorizons Implant Systems Inc. |
| K250295 | Dentsply Sirona Titanium Bases system | Apr 30, 2025 | Substantially Equivalent | Dentsply Sirona |
| K242542 | Medentika CAD/CAM Abutments | Apr 22, 2025 | Substantially Equivalent | Medentika GmbH |
| K250081 | Atlantis® Abutments in Titanium | Apr 11, 2025 | Substantially Equivalent | Dentsply Sirona |
| K232383 | iPhysio® System | Mar 04, 2025 | Substantially Equivalent | Euroteknika |
| K243278 | Custom Abutments | Feb 21, 2025 | Substantially Equivalent | Institut Straumann AG |
| K243478 | Straumann InLab Validated Workflow | Feb 19, 2025 | Substantially Equivalent | Institut Straumann AG |
| K243212 | DESS Dental Smart Solutions | Feb 14, 2025 | Substantially Equivalent | Terrats Medical SL |
| K242064 | Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut) | Jan 17, 2025 | Substantially Equivalent | Smart Denture Conversions, LLC |
| K243272 | LOCATOR Angled Abutment | Jan 14, 2025 | Substantially Equivalent | Zest Anchors, LLC |
| K242030 | MegaGen Dental Implant Abutment | Jan 13, 2025 | Substantially Equivalent | MegaGen Implant Co., Ltd. |
| K241003 | HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) | Jan 08, 2025 | Substantially Equivalent | Hiossen, Inc. |
| K240346 | NobelProcera Zirconia Implant Bridge | Jan 03, 2025 | Substantially Equivalent | Nobel Biocare AB |
| K242819 | IPD Dental Implant Abutments | Dec 19, 2024 | Substantially Equivalent | IMPLANT PROTESIS DENTAL 2004, S.L. |
| K241616 | ALLONUS Tech Prosthetics | Dec 17, 2024 | Substantially Equivalent | ALLONUS Tech Co., LTD. |
| K242025 | Elos Accurate® Hybrid Base | Dec 10, 2024 | Substantially Equivalent | Elos Medtech Pinol A/S |
| K242703 | LW Pre-milled Abutment | Dec 05, 2024 | Substantially Equivalent | Ossvis Co., Ltd. |
| K242686 | Neodent Implant System | Dec 04, 2024 | Substantially Equivalent | JJGC Indústria e Comércia de Materiais Dentários S.A. |
| K242245 | Customized Abutment | Nov 25, 2024 | Substantially Equivalent | ARUM DENTISTRY Co., Ltd. |
| K241575 | Straumann® Anatomic Healing Abutments XC (AHA) | Nov 11, 2024 | Substantially Equivalent | Straumann USA, LLC |
| K242340 | DESS Dental Smart Solutions | Nov 05, 2024 | Substantially Equivalent | Terrats Medical SL |
| K241170 | Dynamic TiBase; TRI Screws | Oct 21, 2024 | Substantially Equivalent | Talladium España, SL |
| K240725 | PreXolid CAD/CAM abutments | Oct 18, 2024 | Substantially Equivalent | Eclectic Co., Ltd. |
| K241485 | TruAbutment DS; TruBase | Oct 09, 2024 | Substantially Equivalent | TruAbutment Inc. |
| K234142 | TiGEN Abutment, PMMA Abutment and Scan Healing Abutment | Sep 18, 2024 | Substantially Equivalent | MegaGen Implant Co., Ltd. |
| K241722 | Elos Accurate® Hybrid Base; Elos Accurate® Customized Abutment | Sep 13, 2024 | Substantially Equivalent | Elos Medtech Pinol A/S |
| K240982 | DESS Dental Smart Solutions | Aug 26, 2024 | Substantially Equivalent | Terrats Medical SL |
| K231932 | TDS (TECHWIN DENTAL SYSTEM) | Aug 20, 2024 | Substantially Equivalent | Techwin Co., Ltd. |
| K240531 | SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment | Jul 30, 2024 | Substantially Equivalent | BioHorizons Implant Systems Inc. |
| K241063 | s-Clean ScanHealing Abutment | Jul 25, 2024 | Substantially Equivalent | Dentis Co., Ltd. |
| K241032 | BellaTek Bars | Jul 15, 2024 | Substantially Equivalent | Biomet 3i, LLC |
| K240240 | Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems | Jul 12, 2024 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K240570 | IPD Dental Implant Abutments | Jun 07, 2024 | Substantially Equivalent | Implant Protesis Dental 2004, S.L |
| K240603 | Ti-Base & Master Fix | Jun 05, 2024 | Substantially Equivalent | Arum Dentistry Co., Ltd. |
| K233587 | LOCATOR Angled Abutment (Various) | Jun 03, 2024 | Substantially Equivalent | Zest Anchors, LLC |
| K233389 | EK Digital Abutments | May 29, 2024 | Substantially Equivalent | Hiossen, Inc. |
| K233285 | KATANA Zirconia ONE For IMPLANT | May 24, 2024 | Substantially Equivalent | Kuraray Noritake Dental Inc. |
| K231940 | BruxZir® NOW SRC | May 15, 2024 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K234112 | Customized Abutment | May 09, 2024 | Substantially Equivalent | Arum Dentistry Co., Ltd. |
| K234018 | CEREC Cercon 4D Abutment Blocks, CEREC Cercon 4D Abutment System | May 07, 2024 | Substantially Equivalent | Dentsply Sirona |
| K233857 | Neodent Implant System Custom Abutments | May 02, 2024 | Substantially Equivalent | JJGC Indústria e Comércio de Materiais Dentários S.A. |
| K232528 | Protective Cap | Apr 30, 2024 | Substantially Equivalent | Neobiotech Co., Ltd. |
| K240208 | DESS Dental Smart Solutions | Apr 24, 2024 | Substantially Equivalent | Terrats Medical SL |
| K223113 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments | Apr 15, 2024 | Substantially Equivalent | Medentika GmbH |
| K231132 | J & P Click Attachments | Mar 26, 2024 | Substantially Equivalent | J & P Dental Technologies |
| K233167 | LW Implant System Abutment | Mar 25, 2024 | Substantially Equivalent | Ossvis Co., Ltd. |
| K233083 | Osteon Precision Milled Suprastructure | Mar 09, 2024 | Substantially Equivalent | Implant Solutions PTY LTD (aka Osteon Medical) |
| K231210 | DGA Abutment | Mar 05, 2024 | Substantially Equivalent | Modern Dental Laboratory (DG) Co., Ltd. |
| K231915 | Zfx Abutments | Mar 01, 2024 | Substantially Equivalent | Zfx GmbH - a company of ZimVie |
| K231753 | Oneday Implant Abutment | Feb 21, 2024 | Substantially Equivalent | Oneday Biotech Co., Ltd. |
| K233194 | TS Abutment System | Feb 20, 2024 | Substantially Equivalent | Osstem Implant Co., Ltd. |
| K233208 | NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium | Jan 24, 2024 | Substantially Equivalent | Nobel Biocare AB |
| K233450 | MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw | Jan 22, 2024 | Substantially Equivalent | MegaGen Implant Co., Ltd. |
| K232170 | Ti Link Abutment | Jan 12, 2024 | Substantially Equivalent | Izenimplant Co., Ltd. |
| K233316 | DESS Dental Smart Solutions | Jan 05, 2024 | Substantially Equivalent | Terrats Medical SL |
| K231072 | Anthogyr FlexiBase® titanium bases for Axiom® BL | Jan 04, 2024 | Substantially Equivalent | Anthogyr |
| K231307 | Elos Accurate Customized Abutment | Dec 21, 2023 | Substantially Equivalent | Elos Medtech Pinol A/S |
| K231411 | INNO SLA Submerged Hybrid Ti-Base System | Dec 20, 2023 | Substantially Equivalent | Cowellmedi Co., Ltd. |
| K232560 | Angled Abutment | Dec 19, 2023 | Substantially Equivalent | Arum Dentistry Co., Ltd. |
| K231803 | Neodent Implant System - Zirconia Implant System | Dec 13, 2023 | Substantially Equivalent | JJGC Indústria e Comércio de Materiais Dentários S.A. |
| K232750 | BTI Interna Prosthetic Components | Dec 08, 2023 | Substantially Equivalent | B.T.I. Biotechnology Institute, S.L. |
| K232220 | SS Abutment System | Dec 05, 2023 | Substantially Equivalent | Osstem Implant Co., Ltd. |
| K232546 | Meta G UCLA Abutment | Nov 21, 2023 | Substantially Equivalent | Cowellmedi Co., Ltd. |
| K231559 | Multi-Unit DAS System | Nov 17, 2023 | Substantially Equivalent | Talladium España, SL |
| K231097 | Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems | Nov 14, 2023 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K231874 | AOT & T-L Abutment | Oct 30, 2023 | Substantially Equivalent | TruAbutment Inc. |
| K232271 | SIMDA abutment | Oct 26, 2023 | Substantially Equivalent | Simda Co., Ltd. |
| K232151 | Dynamic TiBase | Oct 17, 2023 | Substantially Equivalent | Talladium España, SL |
| K231413 | IPD Dental Implant Abutments | Oct 10, 2023 | Substantially Equivalent | Implant Protesis Dental 2004 S.L. |
| K221972 | Warantec Custom Abutment | Oct 02, 2023 | Substantially Equivalent | Warantec Co., Ltd, |
| K223496 | Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems | Sep 26, 2023 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K231827 | BTI Dental Implant System UnicCa® Aesthetic Post Abutments | Sep 15, 2023 | Substantially Equivalent | B.T.I. Biotechnology Institute, S.L. |
| K231235 | LW UCLA Abutment | Sep 15, 2023 | Substantially Equivalent | Ossvis Co., Ltd. |
| K231079 | LW Retraction Cap | Sep 14, 2023 | Substantially Equivalent | Ossvis Co., Ltd. |
| K230317 | Elos Accurate Hybrid Base | Sep 01, 2023 | Substantially Equivalent | Elos Medtech Pinol A/S |
| K231557 | ZENEX FreeMilling & CCM Cast Abutment | Aug 24, 2023 | Substantially Equivalent | Izenimplant Co., Ltd. |
| K220253 | Eco Abutment, Multiunit Abutment | Aug 18, 2023 | Substantially Equivalent | DIO Corporation |
| K231455 | Implant-One System | Aug 15, 2023 | Substantially Equivalent | Implant Logistics, Inc. |
| K231434 | DESS Dental Smart Solutions | Aug 14, 2023 | Substantially Equivalent | Terrats Medical SL |
| K230126 | Dentis s-Clean Regular Abutment | Aug 04, 2023 | Substantially Equivalent | Dentis Co., Ltd |
| K230873 | Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments | Aug 01, 2023 | Substantially Equivalent | Southern Implants (Pty) Ltd |
| K222026 | Neodent Implant System - Zirconia Implant System | Jul 14, 2023 | Substantially Equivalent | JJGC Industria e Comercio de Materiais Dentarios S.A. |
| K221673 | Bonafix TiBase | Jul 14, 2023 | Substantially Equivalent | Zentek Medical LLC |
| K230307 | Dentis i-Clean System | Jul 11, 2023 | Substantially Equivalent | Dentis Co., Ltd. |
| K223535 | SMARTbase Abutment System | Jun 20, 2023 | Substantially Equivalent | Implant Direct Sybron Manufacturing LLC |
| K230246 | Dentis s-Clean SQ-SL Narrow Implant System | May 25, 2023 | Substantially Equivalent | Dentis Co., Ltd. |
| K230523 | s-Clean Link Abutment Narrow | May 24, 2023 | Substantially Equivalent | Dentis Co., Ltd. |
| K223663 | SIMDA Abutment | May 24, 2023 | Substantially Equivalent | SIMDA Co., Ltd. |
| K222836 | Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs | May 15, 2023 | Substantially Equivalent | Institut Straumann AG |
| K221969 | IU Implant System Abutment | May 12, 2023 | Substantially Equivalent | Warantec Co., Ltd, |
| K230203 | Dentis I-FIX Abutment | May 03, 2023 | Substantially Equivalent | Dentis Co., Ltd. |
| K223677 | Titanium Abutment Blank Nobel Biocare N1 TCC | Apr 28, 2023 | Substantially Equivalent | Nobel Biocare AB |
| K223634 | Customized Abutment | Apr 28, 2023 | Substantially Equivalent | Arum Dentistry Co., Ltd. |
| K222636 | ET Abutment System | Apr 28, 2023 | Substantially Equivalent | Hiossen Inc. |
| K230218 | DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) | Apr 25, 2023 | Substantially Equivalent | Dental Direkt GmbH |
| K230103 | Klockner Abutments | Apr 24, 2023 | Substantially Equivalent | Soadco, S.L. |
| K222469 | TIB Abutments | Apr 17, 2023 | Substantially Equivalent | Southern Implants (Pty) Ltd |
| K230143 | DESS Dental Smart Solutions | Apr 13, 2023 | Substantially Equivalent | Terrats Medical SL |
| K230069 | S.I.N. Dental Implant System | Apr 06, 2023 | Substantially Equivalent | S.I.N. Sistema de Implante Nacional S.A. |
| K212394 | Implant-One Multi-Unit Abutment | Mar 23, 2023 | Substantially Equivalent | Implant Logistics, Inc. |
| K221402 | CEREC Tessera Abutment Block, CEREC Tessera Abutment System | Mar 22, 2023 | Substantially Equivalent | Dentsply Sirona Inc. |
| K221301 | DESS Dental Smart Solutions | Mar 09, 2023 | Substantially Equivalent | Terrats Medical SL |
| K222451 | SAVE GBR | Feb 07, 2023 | Substantially Equivalent | Dentis Co., Ltd. |
| K223395 | Luna Dental Implant System | Feb 03, 2023 | Substantially Equivalent | Shinhung MST Co., Ltd |
| K222913 | s-Clean Link Abutment | Jan 13, 2023 | Substantially Equivalent | Dentis Co., Ltd. |
| K222976 | MU System | Jan 12, 2023 | Substantially Equivalent | Dentis Co., Ltd |
| K191111 | DD Solid Connect® CAD/CAM Abutments | Jan 11, 2023 | Substantially Equivalent | Dental Direkt GmbH |
| K222984 | BioClean Implant Restorative System | Dec 29, 2022 | Substantially Equivalent | BioClean Dental, LLC |
| K220390 | CreoDent Solidex Customized Abutment and Screw | Dec 02, 2022 | Substantially Equivalent | CreoDent Prosthetics, Ltd. |
| K222368 | MIST IC | Dec 01, 2022 | Substantially Equivalent | Imagine Milling Technologies, LLC |
| K222044 | Elos Accurate Customized Abutment | Nov 30, 2022 | Substantially Equivalent | Elos Medtech Pinol A/S |
| K220562 | TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment | Nov 10, 2022 | Substantially Equivalent | MegaGen Implant Co., Ltd. |
| K222288 | DESS Dental Smart Solutions | Oct 27, 2022 | Substantially Equivalent | Terrats Medical SL |
| K222269 | DESS Dental Smart Solutions | Oct 26, 2022 | Substantially Equivalent | Terrats Medical SL |
| K220823 | Preat Abutments | Oct 26, 2022 | Substantially Equivalent | Preat Corporation |
| K222215 | IPD Dental Implant Abutments | Oct 21, 2022 | Substantially Equivalent | Implant Protesis Dental 2004 S.L |
| K213106 | BTI Interna Dental Implant System UnicCa - Prosthetic Components | Oct 20, 2022 | Substantially Equivalent | B.T.I. Biotechnology Institute, SL. |
| K202144 | A.B. Dental Devices Dental Implants System | Sep 23, 2022 | Substantially Equivalent | A.B. Dental Device Ltd. |
| K220339 | Esthetic Abutments Nobel Biocare N1 | Sep 16, 2022 | Substantially Equivalent | Nobel Biocare Services AG |
| K221966 | Dynamic TiBase | Sep 15, 2022 | Substantially Equivalent | Talladium Espana, SL |
| K221684 | Osstem Abutment System | Sep 08, 2022 | Substantially Equivalent | Osstem Implant Co., Ltd. |
| K221381 | KDG Abutments | Aug 10, 2022 | Substantially Equivalent | Keystone Dental Inc. |
| K220048 | NobelProcera Zirconia N1 Base | Jul 29, 2022 | Substantially Equivalent | Nobel Biocare Services AG |
| K213961 | TruAbutment DS, TruBase | Jul 14, 2022 | Substantially Equivalent | TruAbutment Inc. |
| K221019 | Osteon Precision Milled Suprastructure | Jul 05, 2022 | Substantially Equivalent | Implant Solutions PTY LTD (aka Osteon Medical) |
| K220482 | Sherlock | Jun 21, 2022 | Substantially Equivalent | Open Implants, LLC |
| K220878 | Straumann TLX Variobase C | Jun 16, 2022 | Substantially Equivalent | Institut Straumann AG |
| K220440 | Dentis s-Clean Abutment Mini | Jun 16, 2022 | Substantially Equivalent | Dentis Co., Ltd. |
| K220612 | PrimeLOC Attachment System | Jun 06, 2022 | Substantially Equivalent | Innovative Product Brands, Inc. |
| K220751 | Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA | Jun 02, 2022 | Substantially Equivalent | Institut Straumann AG |
| K211396 | Neoss Individual Prosthetics | May 17, 2022 | Substantially Equivalent | Neoss Ltd |
| K220252 | High Retention Attachment System | Apr 14, 2022 | Substantially Equivalent | Zest Anchors, LLC |
| K213063 | TLX SRAs and TLX Gold Abutments | Apr 08, 2022 | Substantially Equivalent | Institut Straumann AG |
| K213432 | MIS Angulated multi-unit abutments | Apr 01, 2022 | Substantially Equivalent | Dentsply Sirona |
| K212628 | DESS Dental Smart Solutions | Mar 11, 2022 | Substantially Equivalent | Terrats Medical SL |
| K212676 | Osteon Precision Milled Suprastructure | Mar 03, 2022 | Substantially Equivalent | Implant Solutions PTY LTD (Osteon Medical) |
| K210356 | Noris Medical Dental Implants System | Feb 04, 2022 | Substantially Equivalent | Noris Medical Ltd |
| K210826 | Healing Abutment, Cover Screw | Feb 03, 2022 | Substantially Equivalent | MegaGen Implant Co., Ltd. |
| K201323 | INNO SLA Submerged Implant System | Jan 25, 2022 | Substantially Equivalent | Cowellmedi Co., Ltd. |
| K213391 | High Retention Attachment System | Jan 11, 2022 | Substantially Equivalent | Zest Anchors, LLC |
| K212730 | BellaTek Encode Emergence Healing Abutments | Dec 21, 2021 | Substantially Equivalent | Biomet 3i LLC |
| K212577 | DESS Dental Smart Solutions | Dec 10, 2021 | Substantially Equivalent | Terrats Medical SL |
| K212664 | Sherlock | Nov 30, 2021 | Substantially Equivalent | Open Implants, LLC |
| K211871 | FAICO Dental Implant System and CAD/CAM Abutments | Nov 18, 2021 | Substantially Equivalent | Faico Medical LLC |
| K213449 | DS Implants abutments provided with the EV connection | Nov 15, 2021 | Substantially Equivalent | Dentsply Sirona |
| K203808 | Multi-unit Abutment, Multi-unit Angled Abutment | Oct 20, 2021 | Substantially Equivalent | MegaGen Implant Co. Ltd. |
| K203750 | Straumann CARES P-Series CAD/CAM System | Oct 09, 2021 | Substantially Equivalent | Institut Straumann AG |
| K212108 | Dynamic TiBase | Sep 24, 2021 | Substantially Equivalent | Talladium España, SL |
| K203649 | TruAbutment DS, TruBase | Sep 15, 2021 | Substantially Equivalent | TruAbutment Inc. |
| K210410 | s-Clean Pre-Milled Abutment Mini | Sep 10, 2021 | Substantially Equivalent | Dentis Co., Ltd. |
| K203344 | Premilled Titanium Block System | Aug 25, 2021 | Substantially Equivalent | InnoBioSurg Co., Ltd. |
| K210362 | s-Clean Pre-Milled Abutment | Aug 19, 2021 | Substantially Equivalent | Dentis Co., Ltd. |
| K200193 | Kisses Plus Implant System | Aug 06, 2021 | Substantially Equivalent | ACHIMHAI Medical Corporation |
| K203464 | DESS Dental Smart Solutions | Aug 04, 2021 | Substantially Equivalent | Terrats Medical SL |
| K203542 | Neodent Implant System - Mini Abutment 60° | Aug 02, 2021 | Substantially Equivalent | JJGC Industria e Comercio de Materiais Dentarios S.A. |
| K211225 | MIS Ti-base abutment | Jul 28, 2021 | Substantially Equivalent | Dentsply Sirona |
| K210903 | IS Multi Unit Abutment System | Jul 23, 2021 | Substantially Equivalent | Neobiotech Co., Ltd. |
| K202579 | TruAbutment DS, TruBase | Jul 08, 2021 | Substantially Equivalent | TruAbutment Inc. |
| K203456 | Straumann CARES M-Series CAD/CAM System | Jun 23, 2021 | Substantially Equivalent | Institut Straumann AG |
| K201842 | TruBase S | Jun 04, 2021 | Substantially Equivalent | TruAbutment Inc. |
| K203240 | AccelX Abutments | Apr 27, 2021 | Substantially Equivalent | Integrated Dental Systems LLC |
| K202909 | CreoDent Solidex Customized Abutment | Apr 02, 2021 | Substantially Equivalent | CreoDent Prosthetics, Ltd. |
| K201197 | TruAbutment DS, TruBase S | Mar 26, 2021 | Substantially Equivalent | TruAbutment Inc. |
| K201681 | Straumann Immediate Temporary Abutments | Mar 18, 2021 | Substantially Equivalent | Institut Straumann AG |
| K203252 | Multi-unit Abutments for CONELOG | Mar 16, 2021 | Substantially Equivalent | BioHorizons Implant Systems, Inc. |
| K201860 | Elos Accurate Hybrid Base | Feb 19, 2021 | Substantially Equivalent | Elos Medtech Pinol A/S |
| K203355 | Straumann TLX Novaloc and Cementable Abutments | Feb 12, 2021 | Substantially Equivalent | Institut Straumann AG |
| K192742 | Straumann Variobase C | Feb 12, 2021 | Substantially Equivalent | Institut Straumann AG |
| K202282 | Neodent Implant System - Zirconia Implant System | Jan 29, 2021 | Substantially Equivalent | JJGC Industria e Comercio de Materiais Dentarios SA |
| K202026 | Blue Sky Bio CAD-CAM Abutments | Dec 18, 2020 | Substantially Equivalent | Blue Sky Bio, LLC |
| K202095 | CreoDent Solidex Customized Abutment and Screw | Dec 16, 2020 | Substantially Equivalent | CreoDent Prosthetics, Ltd. |
| K201711 | CARES Screw - Retained Bars and Bridges (SRBB) | Dec 08, 2020 | Substantially Equivalent | Medentika GmbH |
| K202452 | NobelProcera Zirconia Implant Bridge | Dec 03, 2020 | Substantially Equivalent | Nobel Biocare AB |
| K202418 | Magic UCLA Abutment System | Dec 03, 2020 | Substantially Equivalent | InnoBioSurg Co., Ltd. |
| K202269 | PRE-MILLED Abutment | Nov 25, 2020 | Substantially Equivalent | MIT Global Co., Ltd. |
| K193193 | Telio CAD Abutment Solutions- extra systems | Nov 16, 2020 | Substantially Equivalent | Ivoclar Vivadent, AG |
| K193084 | TIB Abutment System | Oct 27, 2020 | Substantially Equivalent | Southern Implants (Pty) Ltd |
| K200827 | LOCATOR R-Tx | Sep 02, 2020 | Substantially Equivalent | Ivory Super Holdco, Incp. |
| K200597 | Straumann BLX Gold Abutments | Aug 19, 2020 | Substantially Equivalent | Straumann USA, LLC (On behalf of Institut Straumann AG) |
| K193408 | Sirona Dental CAD/CAM System with CEREC Chairside Software | Aug 16, 2020 | Substantially Equivalent | Dentsply Sirona |
| K193046 | Straumann® Retentive System Novaloc TiN Abutments | Aug 13, 2020 | Substantially Equivalent | Institut Straumann AG |
| K200355 | Duranext Abutments | Jul 22, 2020 | Substantially Equivalent | Elegant Dental Corp. |
| K201621 | Magicore II System | Jul 15, 2020 | Substantially Equivalent | InnoBioSurg Co., Ltd. |
| K191152 | MIS Ti-base Abutment | Jul 06, 2020 | Substantially Equivalent | Dentsply Sirona |
| K191913 | TruAbutment DS | Jun 19, 2020 | Substantially Equivalent | TruAbutment Inc. |
| K200753 | IBS Implant System II | Jun 09, 2020 | Substantially Equivalent | InnoBioSurg Co., Ltd. |
| K193404 | UF(II) Bar holder abutment | May 18, 2020 | Substantially Equivalent | DIO Corporation |
| K192218 | Custom Legacy and Custom InterActive Titanium Abutments | May 08, 2020 | Substantially Equivalent | Implant Direct Sybron Manufacturing , LLC |
| K192108 | Panthera Dental Milled Bars | Apr 08, 2020 | Substantially Equivalent | Panthera Dental Inc. |
| K192401 | Straumann Screw-Retained Abutments | Apr 06, 2020 | Substantially Equivalent | Straumann USA, LLC |
| K200040 | Universal Base Conical Connection (CC) | Mar 30, 2020 | Substantially Equivalent | Nobel Biocare AG |
| K193078 | MIS CONNECT Conical Connection System | Mar 25, 2020 | Substantially Equivalent | Dentsply Sirona |
| K193335 | Sherlock | Mar 24, 2020 | Substantially Equivalent | Open Implants, LLC |
| K193425 | Pre-Milled Blank | Mar 09, 2020 | Substantially Equivalent | Arum Dentistry Co. Ltd |
| K193529 | ATLANTIS Abutment for MIS Conical Connection Implants | Mar 05, 2020 | Substantially Equivalent | Dentsply Sirona |
| K193064 | Atlantis suprastructures | Mar 03, 2020 | Substantially Equivalent | Dentsply Sirona Inc. |
| K193274 | Rodo Abutment System | Feb 27, 2020 | Substantially Equivalent | RODO Medical, Inc. |
| K200189 | Luna Dental Implant System- Healing Abutment | Feb 26, 2020 | Substantially Equivalent | Shinhung MST Co., Ltd. |
| K192263 | UCLA CCM Abutment | Feb 21, 2020 | Substantially Equivalent | DIO Corporation |
| K192614 | Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment | Feb 13, 2020 | Substantially Equivalent | MegaGen Implant CO., Ltd. |
| K191919 | Elos Accurate Hybrid Base | Feb 10, 2020 | Substantially Equivalent | Elos Medtech Pinol A/S |
| K191890 | Elos Accurate Customized Abutment | Feb 06, 2020 | Substantially Equivalent | Elos Medtech Pinol A/S |
| K183106 | TruAbutment DS | Jan 29, 2020 | Substantially Equivalent | TruAbutment Inc. |
| K192436 | Healing Abutments and Cover Screws | Jan 23, 2020 | Substantially Equivalent | Dentium Co., Ltd. |
| K191123 | Multi-unit Abutments | Jan 06, 2020 | Substantially Equivalent | Medentika GmbH |
| K192893 | Straumann Ceramic Healing Abutments | Jan 03, 2020 | Substantially Equivalent | Institut Straumann AG |
| K192457 | Elos Accurate Customized Abutment | Jan 02, 2020 | Substantially Equivalent | Elos Medtech Pinol A/S |
| K192229 | Neodent Implant System- GM Titanium Base for Bridge | Dec 19, 2019 | Substantially Equivalent | JJGC Industria e Comercio de Materiais Dentarios S.A. |
| K192522 | TSV BellaTek Express and BellaTek Flex Abutments | Dec 09, 2019 | Substantially Equivalent | Biomet 3i LLC |
| K191250 | Southern Implants PEEK Abutments | Dec 05, 2019 | Substantially Equivalent | Southern Implants (Pty) Ltd |
| K191191 | Neodent Implant System - Temporary Abutments | Dec 05, 2019 | Substantially Equivalent | JJGC Industria e Comercio de Materiais Dentarios S.A. |
| K191986 | DESS Dental Smart Solutions | Nov 10, 2019 | Substantially Equivalent | Terrats Medical SL |
| K191634 | Scan Abutments and Comfort Caps | Nov 04, 2019 | Substantially Equivalent | Dentium Co., Ltd. |
| K192029 | Straumann PUREloc abutments | Oct 28, 2019 | Substantially Equivalent | Institut Straumann AG |
| K191458 | Legacy SMARTBase Abutments | Oct 10, 2019 | Substantially Equivalent | Implant Direct Sybron Manufacturing LLC |
| K190048 | UF(II) Anatomic abutment | Sep 30, 2019 | Substantially Equivalent | DIO Corporation |
| K191382 | IPS e.max CAD Abutment Solutions- extra systems | Aug 26, 2019 | Substantially Equivalent | Ivoclar Vivadent, AG |
| K190491 | Blue Sky Bio Zygomatic Implant System | Aug 12, 2019 | Substantially Equivalent | Blue Sky Bio, LLC. |
| K191222 | Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV | Aug 05, 2019 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K182455 | A.B. DENTAL DEVICES Dental Implants System | Jul 15, 2019 | Substantially Equivalent | A.B. Dental Device Ltd. |
| K182091 | Osstem Abutment System | Jul 12, 2019 | Substantially Equivalent | Osstem Implant Co., Ltd. |
| K183079 | Conometric Abutments | Jul 10, 2019 | Substantially Equivalent | Dentsply Sirona Inc. |
| K183138 | Certain BellaTek Express and BellaTek Flex Abutments | Jul 02, 2019 | Substantially Equivalent | Biomet 3i |
| K190654 | Straumann CI RD Ceramic Healing Caps | Jun 28, 2019 | Substantially Equivalent | Institut Straumann AG |
| K190299 | Elos Accurate® Customized Abutment | Jun 26, 2019 | Substantially Equivalent | Elos Medtech Pinol A/S |
| K190097 | Straumann CARES Screw-Retained Bridges and Bars | Jun 26, 2019 | Substantially Equivalent | Institut Straumann AG |
| K183580 | Panthera Dental Milled Bars | Jun 20, 2019 | Substantially Equivalent | Panthera Dental Inc. |
| K173570 | SD Abutment | May 17, 2019 | Substantially Equivalent | Surgident Co., Ltd. |
| K190082 | Straumann BLX Variobase Abutment | Apr 17, 2019 | Substantially Equivalent | Institut Straumann AG |
| K182246 | MIST IC | Apr 16, 2019 | Substantially Equivalent | Imagine Milling Technologies, LLC |
| K190040 | Straumann BLX Line Extension - New Abutments | Apr 08, 2019 | Substantially Equivalent | Institut Straumann AG |
| K183518 | Preat Abutments | Mar 18, 2019 | Substantially Equivalent | Preat Corporation |
| K181580 | Cortex CAD/CAM Abutments | Jan 29, 2019 | Substantially Equivalent | Cortex Dental Implants Industries Ltd. |
| K182228 | MIS LOCKiT Abutments System, OT-Equators and Ball Attachments | Jan 28, 2019 | Substantially Equivalent | MIS Implants Technologies Ltd. |
| K180564 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases | Jan 07, 2019 | Substantially Equivalent | Medentika GmbH |
| K181037 | DIO CAD/CAM Abutment | Dec 21, 2018 | Substantially Equivalent | DIO Corporation |
| K181869 | On1 Universal Abutment | Dec 12, 2018 | Substantially Equivalent | Nobel Biocare AB |
| K181381 | A.B. Dental Devices Dental Implants System | Nov 23, 2018 | Substantially Equivalent | A.B Dental Device Ltd. |
| K180184 | Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System | Nov 16, 2018 | Substantially Equivalent | Dentalpoint AG |
| K180899 | Universal Base Abutment | Oct 31, 2018 | Substantially Equivalent | Nobel Biocare AB |
| K181520 | Sirona Dental CAD/CAM System | Oct 11, 2018 | Substantially Equivalent | Dentsply Sirona |
| K173945 | Straumann SC Variobase Abutments | Oct 05, 2018 | Substantially Equivalent | Institut Straumann AG |
| K180998 | BioHorizons CAD/CAM Bars | Sep 28, 2018 | Substantially Equivalent | BioHorizons Implant Systems, Inc. |
| K171532 | TruBase S | Sep 11, 2018 | Substantially Equivalent | TruAbutment Inc. |
| K181359 | InterActive SMARTBase Abutments | Aug 15, 2018 | Substantially Equivalent | Implant Direct Sybron Manufacturing LLC |
| K181189 | ATLANTIS Conus Structure | Jul 18, 2018 | Substantially Equivalent | Dentsply Sirona |
| K173968 | Straumann Variobase for Bridge/Bar Cylindrical | Jul 17, 2018 | Substantially Equivalent | Institut Straumann AG |
| K173908 | DESS Dental Smart Solutions | Jun 15, 2018 | Substantially Equivalent | Terrats Medical SL |
| K180609 | Rodo Smilekey | May 23, 2018 | Substantially Equivalent | Rodo Medical, Inc. |
| K172430 | ArgenIS Titanium Abutments | May 18, 2018 | Substantially Equivalent | Argen Corporation |
| K172640 | Dentium Implantium & SuperLine Prosthetics | May 14, 2018 | Substantially Equivalent | Dentium Co., Ltd. |
| K162021 | 3.0 Dynamic TiBase | May 04, 2018 | Substantially Equivalent | TALLADIUM ESPANA, SL |
| K173902 | Neodent Implant System GM Line | Apr 20, 2018 | Substantially Equivalent | JJGC Industria e Comercio de Materiais Dentarios S.A. |
| K171409 | OT EQUATOR | Apr 09, 2018 | Substantially Equivalent | Rhein'83 SRL |
| K173379 | Straumann Variobase for Crown AS | Mar 30, 2018 | Substantially Equivalent | Institut Straumann AG |
| K173326 | MIS CONNECT Conical Connection Abutment | Mar 16, 2018 | Substantially Equivalent | MIS Implants Technologies LTD. |
| K173120 | CCM Abutment System | Mar 16, 2018 | Substantially Equivalent | InnoBioSurg Co., Ltd. |
| K171649 | Straumann CARES M-Series CAD/CAM System | Feb 22, 2018 | Substantially Equivalent | Institut Straumann AG |
| K172160 | Southern Implants PEEK Abutments | Feb 09, 2018 | Substantially Equivalent | Southern Implants (Pty) Ltd |
| K161989 | PREMIUM Implant Systems SHELTA Implant Systems | Feb 01, 2018 | Substantially Equivalent | SWEDEN & MARTINA S.p.A. |
| K173466 | Panthera Dental Milled Bars | Jan 26, 2018 | Substantially Equivalent | Panthera Dental Inc. |
| K172304 | TruAbutment DS | Jan 23, 2018 | Substantially Equivalent | TruAbutment Inc. |
| K171799 | Elos Accurate Customized Abutment, Elos Prosthetic Screw | Jan 15, 2018 | Substantially Equivalent | Elos Medtech Pinol A/S |
| K171622 | Dentium Ti-Base | Jan 11, 2018 | Substantially Equivalent | Dentium Co., Ltd. |
| K170421 | ET Hybrid Abutment | Jan 11, 2018 | Substantially Equivalent | Hiossen Inc. |
| K172798 | Straumann CARES Abutments CoCr | Jan 03, 2018 | Substantially Equivalent | Institut Straumann AG |
| K172854 | NobelPerfect Abutments | Dec 14, 2017 | Substantially Equivalent | Nobel Biocare AB |
| K173374 | TSV BellaTek Encode Healing Abutments | Dec 13, 2017 | Substantially Equivalent | Biomet 3i |
| K171773 | Straumann n!ce Glass Ceramic A14 Blocks | Dec 01, 2017 | Substantially Equivalent | Institut Straumann AG |
| K172225 | Atlantis Abutment for MIS Implant | Nov 30, 2017 | Substantially Equivalent | Dentsply Sirona |
| K171694 | s-Clean TiN Coating Abutments | Nov 29, 2017 | Substantially Equivalent | Dentis Co., Ltd. |
| K171466 | NobelDesign, DTX Studio Design | Nov 29, 2017 | Substantially Equivalent | Nobel Biocare AB |
| K171757 | Straumann Screw Retained Abutments | Nov 27, 2017 | Substantially Equivalent | Straumann USA, LLC (on behalf of Institut Straumann AG) |
| K170022 | Klockner Vega TiBase for CEREC | Nov 16, 2017 | Substantially Equivalent | SOADCO S.L. |
| K170080 | Neodent Implant System - CM Pro PEEK Abutment | Nov 02, 2017 | Substantially Equivalent | JJGC Industria e Comercio de Materiais Dentarios SA |
| K171142 | Healing Cap Multi-Unit Titanium | Oct 26, 2017 | Substantially Equivalent | Nobel Biocare AB |
| K171922 | Anatotemp Anatomic Dental Implant Healing Abutment | Sep 28, 2017 | Substantially Equivalent | Buckeye Medical Technologies LLC |
| K162848 | Straumann CARES Golden Ti/TiN Abutments | Sep 22, 2017 | Substantially Equivalent | INSTITUT STRAUMANN AG |
| K170013 | Eztetic BellaTek Encode Healing Abutments | Sep 21, 2017 | Substantially Equivalent | BIOMET 3I |
| K170838 | Medentika CAD/CAM TiBases | Sep 15, 2017 | Substantially Equivalent | Medentika GmbH |
| K170384 | Dentium NR Line CAD/CAM Abutments | Aug 17, 2017 | Substantially Equivalent | Dentium Co., Ltd. |
| K163398 | ATLANTIS suprastructures | Aug 14, 2017 | Substantially Equivalent | Dentsply Sirona |
| K170588 | DESS Dental Smart Solutions | Aug 08, 2017 | Substantially Equivalent | Terrats Medical SL |
| K162633 | Custom Bars | Jul 24, 2017 | Substantially Equivalent | IMPLANT DIRECT SYBRON MANUFACTURING, LLC |
| K170100 | CreoDent Solidex Customized Abutment and Screw | Jul 18, 2017 | Substantially Equivalent | CreoDent Prosthetics, Ltd. |
| K170356 | Straumann Variobase Abutments | Jun 07, 2017 | Substantially Equivalent | Institut Straumann AG |
| K170354 | Straumann Variobase Abutments | Jun 07, 2017 | Substantially Equivalent | Institut Straumann AG |
| K170044 | Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System | Jun 06, 2017 | Substantially Equivalent | PRISMATIK DENTALCRAFT, INC. |
| K170259 | TruAbutment DS | May 25, 2017 | Substantially Equivalent | TRUABUTMENT |
| K161689 | OSSTEM Implant System - Abutment | May 22, 2017 | Substantially Equivalent | OSSTEM IMPLANT Co., Ltd. |
| K162734 | CreoDent Solidex Customized Abutment | May 08, 2017 | Substantially Equivalent | CreoDent Prosthetics, Ltd. |
| K160670 | ET US SS Prosthetic system | Apr 25, 2017 | Substantially Equivalent | OSSTEM IMPLANT CO., LTD. |
| K163350 | Multibase Abutments EV and ATLANTIS Suprastructures | Mar 31, 2017 | Substantially Equivalent | DENTSPLY SIRONA |
| K162028 | PREMIUM - SHELTA Prosthetic Components | Mar 24, 2017 | Substantially Equivalent | SWEDEN & MARTINA S.p.A. |
| K161416 | Multi-unit Abutment Plus | Mar 16, 2017 | Substantially Equivalent | NOBEL BIOCARE AB |
| K161655 | On1 Concept | Feb 28, 2017 | Substantially Equivalent | NOBEL BIOCARE AB |
| K162390 | ET Hybrid Abutment | Jan 30, 2017 | Substantially Equivalent | HIOSSEN INC. |
| K161713 | Dentium CAD/CAM Abutments | Dec 16, 2016 | Substantially Equivalent | Dentium Co., Ltd |
| K160798 | IPS e.max® Press Abutment Solutions for Viteo Base Ti | Dec 15, 2016 | Substantially Equivalent | IVOCLAR VIVADENT AG |
| K162004 | PREMIUM Implant Systems SHELTA Implant Systems | Dec 05, 2016 | Substantially Equivalent | SWEDEN & MARTINA S.p.A. |
| K153015 | Transfer & Angled Abutment | Dec 05, 2016 | Substantially Equivalent | Osstem Implant Co., Ltd |
| K161435 | Temporary Snap Abutment | Nov 22, 2016 | Substantially Equivalent | Nobel Biocare AB |
| K160786 | RODO Abutment System | Nov 21, 2016 | Substantially Equivalent | RODO MEDICAL, INC |
| K160132 | Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC | Nov 21, 2016 | Substantially Equivalent | HAGER & MEISINGER GMBH |
| K160979 | Inclusive Abutments | Nov 04, 2016 | Substantially Equivalent | PRISMATIK DENTALCRAFT, INC. |
| K160519 | Link Abutment for CEREC | Oct 28, 2016 | Substantially Equivalent | Osstem Implant Co., Ltd |
| K161677 | Straumann Sterile Healing Solution | Oct 07, 2016 | Substantially Equivalent | Institut Straumann AG |
| K160436 | CreoDent Solidex Custom Abutment | Sep 29, 2016 | Substantially Equivalent | CreoDent Prosthetics, Ltd. |
| K160207 | ATLANTIS ISUS Implant Suprastructures | Sep 21, 2016 | Substantially Equivalent | DENTSPLY INTERNATIONAL, INC. |
| K160964 | Neodent Implant System - Titanium Base for CEREC | Sep 16, 2016 | Substantially Equivalent | JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA |
| K160828 | Dentium Implantium & SuperLine Prosthetics | Sep 15, 2016 | Substantially Equivalent | DENTIUM CO., LTD. |
| K160784 | CAM Titanium Blanks | Sep 14, 2016 | Substantially Equivalent | ALTATEC GMBH |
| K160626 | ATLANTIS Abutment for HIOSSEN ET implant | Aug 29, 2016 | Substantially Equivalent | DENTSPLY SIRONA |
| K161030 | ATLANTIS Abutment for CONELOG implant | Aug 26, 2016 | Substantially Equivalent | Dentsply Sirona |
| K153509 | GPS Angled Abutment | Aug 26, 2016 | Substantially Equivalent | IMPLANT DIRECT SYBRON MANUFACTURING LLC |
| K160382 | OT EQUATOR | Aug 11, 2016 | Substantially Equivalent | RHEIN'83 SRL |
| K160483 | Burn-out Cylinder and Angled Screw Abutments | Aug 05, 2016 | Substantially Equivalent | Dentium Co., Ltd |
| K160248 | ArgenIS Titanium Abutments | Aug 05, 2016 | Substantially Equivalent | Argen Corporation |
| K160158 | NobelProcera HT ML FCZ Implant Bridge and Framework | Jul 25, 2016 | Substantially Equivalent | Nobel Biocare AB |
| K153645 | VITA ENAMIC Implant Solutions (IS) | Jun 30, 2016 | Substantially Equivalent | VITA ZAHNFABRIK H. RAUTER GMBH CO. |
| K160244 | VARIOunite | Jun 02, 2016 | Substantially Equivalent | Thommen Medical AG |
| K153036 | NobelDesign Software | Jun 02, 2016 | Substantially Equivalent | NOBEL BIOCARE AB |
| K152559 | TruAbutment DS | May 20, 2016 | Substantially Equivalent | TRUABUTMENT |
| K153624 | Neodent Implant System | Apr 15, 2016 | Substantially Equivalent | JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S |
| K151608 | 4plus6Line Abutment System | Apr 13, 2016 | Substantially Equivalent | OT MEDICAL GMBH |
| K153779 | Abutment for Bridges | Mar 31, 2016 | Substantially Equivalent | ALTATEC GmbH |
| K152845 | Allied Biocompat Abutment for Nobel Replace Interface | Mar 14, 2016 | Substantially Equivalent | ALLIED DENTAL SOLUTIONS |
| K151984 | Thommen Milling Abutment for CAD/CAM | Mar 10, 2016 | Substantially Equivalent | THOMMEN MEDICAL AG |
| K151789 | LOCATOR F-Tx Attachment System | Mar 04, 2016 | Substantially Equivalent | ZEST ANCHORS, LLC |
| K151590 | Straumann RN Gold Abutment for Bridge | Mar 04, 2016 | Substantially Equivalent | STRAUMANN USA, LLC |
| K151439 | ATLANTIS ISUS | Feb 19, 2016 | Substantially Equivalent | DENTSPLY INTERNATIONAL, INC. |
| K151194 | KLOCKNER DENTAL IMPLANT ABUTMENTS (II) | Jan 29, 2016 | Substantially Equivalent | SOADCO, S.L. |
| K151039 | ATLANTIS Abutment for NobelActive 3.0 | Jan 14, 2016 | Substantially Equivalent | DENTSPLY INTERNATIONAL, INC. |
| K151621 | BioHorizons CAD/CAM Abutments | Jan 13, 2016 | Substantially Equivalent | BIOHORIZONS IMPLANT SYSTEMS, INC. |
| K152509 | CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR) | Jan 12, 2016 | Substantially Equivalent | ALTATEC GMBH |
| K151295 | Biodenta Customized Abutment - Titanium | Dec 01, 2015 | Substantially Equivalent | BIODENTA SWISS AG |
| K142211 | OT EQUATOR | Nov 25, 2015 | Substantially Equivalent | Rhein '83 SRL |
| K151798 | Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System | Nov 16, 2015 | Substantially Equivalent | PRISMATIK DENTALCRAFT, INC. |
| K151432 | NaturalLine Abutment | Nov 05, 2015 | Substantially Equivalent | OT MEDICAL GMBH |
| K150203 | Medentika CAD/CAM Abutments | Oct 23, 2015 | Substantially Equivalent | MEDENTIKA GMBH |
| K151169 | OsteoReady ZircoSeal Abutments | Oct 08, 2015 | Substantially Equivalent | OsteoReady LLC |
| K150669 | Neoss TiBase, Neoss CoCr Abutments (Mono and Multi) | Oct 08, 2015 | Substantially Equivalent | Neoss Ltd |
| K151375 | Inclusive Titanium Abutments compatible with: Hiossen HG Implant System | Oct 07, 2015 | Substantially Equivalent | PRISMATIK DENTALCRAFT, INC. |
| K143515 | Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants | Oct 01, 2015 | Substantially Equivalent | PRISMATIK DENTALCRAFT, INC. |
| K151564 | Telio CAD Abutment Solutions | Sep 21, 2015 | Substantially Equivalent | IVOCLAR VIVADENT AG |
| K150899 | Straumann CARES Titanium Alloy (TAN) Abutment | Sep 16, 2015 | Substantially Equivalent | STRAUMANN USA, LLC |
| K143051 | ArgenIS Titanium Abutments | Sep 16, 2015 | Substantially Equivalent | THE ARGEN CORPORATION |
| K151324 | Straumann Variobase for CEREC | Sep 11, 2015 | Substantially Equivalent | STRAUMANN USA, LLC |
| K151247 | NC Straumann Screw Retained Abutments | Aug 10, 2015 | Substantially Equivalent | STRAUMANN USA, LLC |
| K150814 | Straumann Screw-Retained Abutment | Aug 10, 2015 | Substantially Equivalent | STRAUMANN USA, LLC |
| K151157 | NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variobase Abutment for Bars/Bridges, RN Straumann Variobase Abutment for Bars/Bridges, WN Straumann Variobase Abutment for Bars/Bridges | Aug 05, 2015 | Substantially Equivalent | STRAUMANN USA, LLC |
| K141970 | DIGITEK TITANIUM ABUTMENT | Jul 31, 2015 | Substantially Equivalent | DIGITEK DENTAL SOLUTIONS LIMITED |
| K150295 | LOCATOR RTx | Jul 24, 2015 | Substantially Equivalent | ZEST ANCHORS, INC. |
| K150367 | Neodent Implant System | Jul 13, 2015 | Substantially Equivalent | JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S |
| K150296 | Biodenta Customized Abutment-Hybrid | Jul 02, 2015 | Substantially Equivalent | BIODENTA SWISS AG |
| K143505 | Zimmer Patient-Specific Abutment, Internal Hex, Titanium | Jun 25, 2015 | Substantially Equivalent | Zimmer Dental, Inc. |
| K150250 | SternSnap Angled Attachment | Jun 11, 2015 | Substantially Equivalent | Sterngold Dental, LLC |
| K150012 | CreoDent Solidex Customized Abutment | Jun 04, 2015 | Substantially Equivalent | CREODENT PROSTHETICS, LTD. |
| K143528 | Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System | May 01, 2015 | Substantially Equivalent | ZIMMER DENTAL INC. |
| K142167 | MEDENTIKA ABUTMENT SYSTEM | Feb 20, 2015 | Substantially Equivalent | MEDENTIKA GMBH |
| K143337 | CONELOG Titanium base CAD/CAM | Feb 17, 2015 | Substantially Equivalent | ALTATEC GMBH |
| K142572 | Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System | Jan 21, 2015 | Substantially Equivalent | Zimmer Dental, Inc. |
| K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit | Jan 09, 2015 | Substantially Equivalent | STRAUMANN USA, LLC |
| K141923 | INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X | Jan 06, 2015 | Substantially Equivalent | PRISMATIK DENTALCRAFT, INC. |
| K142407 | Straight Stud Attachment | Dec 24, 2014 | Substantially Equivalent | Sterngold Dental, LLC |
| K142118 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE | Nov 25, 2014 | Substantially Equivalent | PRISMATIK DENTALCRAFT, INC. |
| K142115 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT | Nov 13, 2014 | Substantially Equivalent | PRISMATIK DENTALCRAFT, INC. |
| K141457 | DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS | Nov 12, 2014 | Substantially Equivalent | DENTIUM CO. LTD. |
| K141544 | ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM | Oct 22, 2014 | Substantially Equivalent | ZIMMER DENTAL INC. |
| K141211 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS | Oct 22, 2014 | Substantially Equivalent | PRISMATIK DENTALCRAFT, INC. |
| K140600 | SB ANCHOR | Aug 21, 2014 | Substantially Equivalent | OSSTEM IMPLANT CO., LTD. |
| K140507 | HIOSSEN PROSTHETIC SYSTEM | Aug 20, 2014 | Substantially Equivalent | OSSTEM IMPLANT CO., LTD. |
| K140737 | STRAUMANN CARES SCREW RETAINED BARS/BRIDGE | Aug 14, 2014 | Substantially Equivalent | STRAUMANN USA, LLC |
| K141871 | Straumann Bone Level NC Angled Screw Retained Abutments | Aug 07, 2014 | Substantially Equivalent | STRAUMANN USA, LLC |
| K141120 | ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM | Jul 29, 2014 | Substantially Equivalent | ZIMMER DENTAL INC. |
| K132749 | NOBELPROCERA OVERDENTURE BAR | Jul 24, 2014 | Substantially Equivalent | NOBEL BIOCARE USA, LLC |
| K133551 | ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM | Jul 18, 2014 | Substantially Equivalent | ZIMMER DENTAL INC. |
| K132214 | ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE | Jul 07, 2014 | Substantially Equivalent | HAGER & MEISINGER GMBH |
| K131468 | DENRACLE DENTAL ABUTMENT | May 06, 2014 | Substantially Equivalent | GREEN DENTECH CO LTD |
| K134045 | ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEM | Apr 25, 2014 | Substantially Equivalent | ZIMMER DENTAL INC. |
| K133421 | STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW | Apr 17, 2014 | Substantially Equivalent | STRAUMANN USA, LLC |
| K133791 | ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S] | Apr 16, 2014 | Substantially Equivalent | STERNGOLD DENTAL LLC |
| K133377 | NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE | Apr 04, 2014 | Substantially Equivalent | NOBEL BIOCARE AB |
| K130618 | SFI-ANCHOR | Mar 03, 2014 | Substantially Equivalent | CENDRES & METAUX SA |
| K133696 | NEODENT IMPLANT SYSTEM | Feb 25, 2014 | Substantially Equivalent | JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S |
| K132814 | SFI-BAR IMPLANT ABUTMENTS | Feb 25, 2014 | Substantially Equivalent | STERNGOLD DENTAL LLC |
| K132219 | STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN, | Feb 21, 2014 | Substantially Equivalent | STRAUMANN USA, LLC |
| K132746 | NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION | Jan 30, 2014 | Substantially Equivalent | NOBEL BIOCARE USA, LLC |
| K131644 | ANKYLOS SYNCONE ABUTMENT 5(DEGREE) | Jan 22, 2014 | Substantially Equivalent | DENTSPLY INTERNATIONAL, INC. |
| K132844 | STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES | Jan 15, 2014 | Substantially Equivalent | STRAUMANN USA, LLC |
| K130662 | ET PROSTHETIC SYSTEM | Jan 10, 2014 | Substantially Equivalent | OSSTEM IMPLANT CO.,LTD |
| K132067 | MULTI ANGLED ABUTMENT SYSTEM | Dec 20, 2013 | Substantially Equivalent | HIOSSEN INC. |
| K132209 | IPS E.MAX CAD ABUTMENT SOLUTIONS | Oct 31, 2013 | Substantially Equivalent | IVOCLAR VIVADENT AG |
| K122295 | CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS | Oct 24, 2013 | Substantially Equivalent | CORE 3D PROTECH, S.L. |
| K131526 | SFI-BAR | Sep 23, 2013 | Substantially Equivalent | CENDRES & METAUX SA |
| K113738 | CREODENT SOLIDEX CUSTOM ABUTMENT | Sep 17, 2013 | Substantially Equivalent | CREODENT PROSTHETICS LTD. |
| K131101 | ITERO SOFTWARE | Aug 26, 2013 | Substantially Equivalent | CADENT, LTD. AN ALIGN TECHNOLOGY COMPANY |
| K122988 | KLOCKNER DENTAL IMPLANT ABUTMENTS | Jul 19, 2013 | Substantially Equivalent | SOADCO, S.L. |
| K130183 | SFI BAR ABUTMENTS | Jul 07, 2013 | Substantially Equivalent | STERNGOLD DENTAL LLC |
| K122424 | ISUS IMPLANT SUPRASTRUCTURES | Jul 05, 2013 | Substantially Equivalent | DENTSPLY INTERNATIONAL, INC. |
| K130408 | ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT | Jul 01, 2013 | Substantially Equivalent | STERNGOLD DENTAL LLC |
| K130808 | STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS | Jun 28, 2013 | Substantially Equivalent | STRAUMANN USA |
| K123627 | ET SMARTFIT ABUTMENT | Jun 28, 2013 | Substantially Equivalent | HIOSSEN INC. |
| K130310 | CERTAIN BELLATEK PROVISIONAL ABUTMENTS | Jun 21, 2013 | Substantially Equivalent | BIOMET 3I |
| K120954 | NOBELPROCERA PEEK ABUTMENTS | Jun 05, 2013 | Substantially Equivalent | NOBEL BIOCARE AB |
| K123491 | BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT | May 30, 2013 | Substantially Equivalent | BIODENTA SWISS AG |
| K122559 | BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS | May 03, 2013 | Substantially Equivalent | BIODENTA SWISS AG |
| K130216 | ATLANTIS STRAUMANN BONE LEVEL ABUTMENT | May 01, 2013 | Substantially Equivalent | DENTSPLY IMPLANT |
| K123755 | MULTI ANGLED ABUTMENT | Apr 26, 2013 | Substantially Equivalent | OSSTEM IMPLANT CO., LTD |
| K124008 | IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE | Mar 29, 2013 | Substantially Equivalent | IVOCLAR VIVADENT, AGIN |
| K122602 | NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS | Mar 13, 2013 | Substantially Equivalent | NOBEL BIOCARE AB |
| K113816 | GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV | Jan 30, 2013 | Substantially Equivalent | GC AMERICA, INC. |
| K121810 | OSSEOSPEED ANGLED ABUTMENT EV | Jan 23, 2013 | Substantially Equivalent | ASTRA TECH AB |
| K120822 | STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, ST | Dec 21, 2012 | Substantially Equivalent | INSTITUT STRAUMANN AG |
| K121117 | NDX ABUTMENTS | Dec 14, 2012 | Substantially Equivalent | NATIONAL DENTEX CORP |
| K122268 | ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS | Dec 11, 2012 | Substantially Equivalent | DENTSPLY INTERNATIONAL |
| K121843 | NP-CAST ABUTMENT SYSTEM | Dec 11, 2012 | Substantially Equivalent | OSSTEM IMPLANT CO.,LTD |
| K121391 | INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS | Dec 10, 2012 | Substantially Equivalent | PRISMATIK DENTALCRAFT, INC. |
| K120858 | IMPLANT BAR | Dec 06, 2012 | Substantially Equivalent | PRISMATIK DENTALCRAFT, INC. |
| K120873 | ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM | Nov 08, 2012 | Substantially Equivalent | ZIMMER DENTAL INC. |
| K122192 | NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEM | Nov 02, 2012 | Substantially Equivalent | STRAUMANN USA, LLC |
| K121709 | ZFX DENTAL CAD SYSTEM | Oct 19, 2012 | Substantially Equivalent | ZIMMER DENTAL INC. |
| K120053 | IPS E.MAX PRESS - ABUTMENT SOLUTIONS | Oct 18, 2012 | Substantially Equivalent | IVOCLAR VIVADENT AG |
| K121688 | MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM | Oct 12, 2012 | Substantially Equivalent | PRISMATIK DENTALCRAFT, INC. |
| K120776 | ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION | Sep 11, 2012 | Substantially Equivalent | BIOMET 3I |
| K121334 | VARIOECO | Aug 14, 2012 | Substantially Equivalent | THOMMEN MEDICAL, AG |
| K112787 | KERATOR | Aug 08, 2012 | Substantially Equivalent | KJ MEDITECH CO., LTD |
| K120338 | ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA | Jul 05, 2012 | Substantially Equivalent | ASTRA TECH INC. |
| K113003 | ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT... | Mar 01, 2012 | Substantially Equivalent | ASTRA TECH INC. |
| K111935 | TI-BASE ABUTMENT, 1 CONNECT ABUTMENT | Feb 17, 2012 | Substantially Equivalent | NT-TRADING GMBH AND CO KG |
| K111421 | SIRONA DENTAL CAD/CAM SYSTEM | Feb 17, 2012 | Substantially Equivalent | SIRONA DENTAL SYSTEMS GMBH |
| K112099 | CONTOUR HEALER | Feb 03, 2012 | Substantially Equivalent | CONTOUR HEALER, LLC |
| K112333 | LRT ATTACHMENT | Jan 30, 2012 | Substantially Equivalent | BCF CERTIFICATION INC. |
| K113606 | NNC GOLD ABUTMENT FOR BRIDGES | Jan 27, 2012 | Substantially Equivalent | STRAUMANN USA |
| K112045 | SIMPLELINE II ABUTMENT SYSTEM | Jan 26, 2012 | Substantially Equivalent | DENTIUM CO., LTD. |
| K113092 | ZIMMER CONTOUR PROVISIONAL COPING | Jan 23, 2012 | Substantially Equivalent | ZIMMER DENTAL INC. |
| K113410 | NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENT | Jan 13, 2012 | Substantially Equivalent | STRAUMANN USA |
| K112730 | ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION | Jan 13, 2012 | Substantially Equivalent | BIOMET 3I |
| K113283 | NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS | Dec 28, 2011 | Substantially Equivalent | STRAUMANN USA |
| K111853 | ANGLED TAPERED ABUTMENT | Dec 08, 2011 | Substantially Equivalent | ZIMMER DENTAL INC. |
| K112138 | ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT | Dec 01, 2011 | Substantially Equivalent | ASTRA TECH, INC. |
| K112280 | STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM | Nov 16, 2011 | Substantially Equivalent | STRAUMANN USA |
| K111984 | SPI VARIO ANGLED ABUTMENT | Nov 10, 2011 | Substantially Equivalent | THOMMEN MEDICAL, AG |
| K103291 | BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE | Nov 04, 2011 | Substantially Equivalent | BIOHORIZONS IMPLANT SYSTEMS, INC. |
| K103691 | BIOHORIZONS ABUTMENTS FOR ZIMMER | Nov 03, 2011 | Substantially Equivalent | BIOHORIZONS IMPLANT SYSTEMS, INC. |
| K112259 | NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS | Oct 28, 2011 | Substantially Equivalent | NOBEL BIOCARE AB |
| K110308 | PROSTHETIC SYSTEM | Oct 03, 2011 | Substantially Equivalent | OSSTEM IMPLANT CO.,LTD |
| K111390 | SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA.. | Sep 12, 2011 | Substantially Equivalent | CENDRES & METAUX SA |
| K110565 | ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE | Sep 01, 2011 | Substantially Equivalent | BIOMET 3I, INC. |
| K110580 | NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS | Aug 12, 2011 | Substantially Equivalent | STRAUMANN USA |
| K111852 | ANODIZED HEALING COLLAR | Aug 11, 2011 | Substantially Equivalent | ZIMMER DENTAL INC. |
| K111199 | INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS | Aug 08, 2011 | Substantially Equivalent | INTRA-LOCK INTERNATIONAL, INC. |
| K110778 | BIODENTA CUSTOMIZED ABUTMENT | Jul 29, 2011 | Substantially Equivalent | BIODENTA SWISS AG |
| K103234 | GC AADVA BO AC ABUTMENTS | Jun 30, 2011 | Substantially Equivalent | GC AMERICA, INC. |
| K111581 | 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVE | Jun 23, 2011 | Substantially Equivalent | NOBEL BIOCARE AB |
| K101005 | ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT | Jun 21, 2011 | Substantially Equivalent | ASTRA TECH AB |
| K110171 | NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS | Jun 15, 2011 | Substantially Equivalent | NOBEL BIOCARE USA LLC |
| K110640 | ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT | Jun 10, 2011 | Substantially Equivalent | ASTRA TECH, INC. |
| K110356 | ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT | Jun 10, 2011 | Substantially Equivalent | ASTRA TECH, INC. |
| K102804 | SPI TITANIUM BASE FOR CAD/CAM | Apr 20, 2011 | Substantially Equivalent | THOMMEN MEDICAL, AG |
| K103759 | ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT | Apr 08, 2011 | Substantially Equivalent | ASTRA TECH, INC. |
| K102467 | UTA AND UHA | Apr 07, 2011 | Substantially Equivalent | UTA |
| K103339 | TDS ABUTMENT FOR FRIADENT XIVE | Mar 31, 2011 | Substantially Equivalent | POU YU BIOTECHNOLOGY CO., LTD. |
| K101608 | BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS | Mar 11, 2011 | Substantially Equivalent | BIOMET 3I, INC. |
| K101607 | BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTS | Mar 11, 2011 | Substantially Equivalent | BIOMET 3I, INC. |
| K103280 | BHDENTAL IMPLANT SYSTEM | Feb 24, 2011 | Substantially Equivalent | BHDENTAL LTD |
| K103020 | ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT | Feb 03, 2011 | Substantially Equivalent | ATLANTIS COMPONENTS, INC. |
| K101890 | BALL ABUTMENT SYSTEM | Feb 03, 2011 | Substantially Equivalent | MEGAGEN CO., LTD. |
| K103252 | CAMLOG VARIO SR ABUTMENTS | Jan 10, 2011 | Substantially Equivalent | ALTATEC GMBH |
| K100993 | INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS | Dec 28, 2010 | Substantially Equivalent | PRISMATIK DENTALCRAFT, INC. |
| K101465 | STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR | Dec 13, 2010 | Substantially Equivalent | INSTITUT STRAUMANN AG |
| K102382 | SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT | Dec 03, 2010 | Substantially Equivalent | CENDRES & METAUX SA |
| K102209 | ENCODE PATIENT SPECIFIC ABUTMENT | Dec 03, 2010 | Substantially Equivalent | BIOMET 3I, INC. |
| K101582 | CAM STRUCTSURE BARS | Nov 08, 2010 | Substantially Equivalent | BIOMET 3I, INC. |
| K100152 | SIRONA CAD/CAM SYSTEM | Oct 22, 2010 | Substantially Equivalent | SIRONA DENTAL SYSTEMS GMBH |
| K100356 | TDS PRECISION DENTAL BAR | Oct 05, 2010 | Substantially Equivalent | POU YU BIOTECHNOLOGY CO., LTD. |
| K100985 | BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK | Sep 09, 2010 | Substantially Equivalent | BIOHORIZONS IMPLANT SYSTEMS, INC. |
| K101714 | NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS | Aug 31, 2010 | Substantially Equivalent | NOBEL BIOCARE AB |
| K101068 | ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS | Aug 23, 2010 | Substantially Equivalent | RADIANT EXPRESS LLC |
| K101798 | SPI VARIOMULTI ANGLED ABUTMENT | Aug 19, 2010 | Substantially Equivalent | THOMMEN MEDICAL, AG |
| K100245 | HS/HG PROSTHETIC SYSTEM | Aug 17, 2010 | Substantially Equivalent | OSSTEM IMPLANT CO.,LTD |
| K101004 | ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT | Aug 16, 2010 | Substantially Equivalent | ASTRA TECH, INC. |
| K093643 | MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS | Jun 24, 2010 | Substantially Equivalent | NOBELBIOCARE AB |
| K090081 | TALLADIUM INTERNATIONAL IMPLANTOLOGY ABUTMENTS | Jun 22, 2010 | Substantially Equivalent | TALLADIUM ESPANA S.L. |
| K093975 | SIMPLER TOADSTOOL ABUTMENT, MODEL S19000-S19009 | Jun 04, 2010 | Substantially Equivalent | PAN GLOBAL IMPLANT |
| K093780 | ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT | Apr 16, 2010 | Substantially Equivalent | ASTRA TECH, INC. |
| K092857 | VERICORE ABUTMENT IN TITANIUM FOR IMPLANT SYSTEMS | Mar 04, 2010 | Substantially Equivalent | WHIP-MIX CORP. |
| K083876 | SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT | Feb 26, 2010 | Substantially Equivalent | CENDRES & METAUX SA |
| K093483 | ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + ABUTMENT | Dec 22, 2009 | Substantially Equivalent | ASTRA TECH INC. |
| K091701 | STRAUMANN MODIFIED DENTAL ABUTMENT | Dec 22, 2009 | Substantially Equivalent | INSTITUT STRAUMANN AG |
| K093113 | ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT | Dec 18, 2009 | Substantially Equivalent | INSTITUT STRAUMANN AG |
| K092814 | STRAUMANN DENTAL ABUTMENTS | Dec 15, 2009 | Substantially Equivalent | STRAUMANN MANUFACTURING, INC. |
| K092341 | LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION | Nov 30, 2009 | Substantially Equivalent | BIOMET 3I, INC. |
| K092377 | PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S | Nov 03, 2009 | Substantially Equivalent | ZIMMER DENTAL INC. |
| K092403 | TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620 | Oct 30, 2009 | Substantially Equivalent | ZIMMER DENTAL INC. |
| K091848 | NOBEL/PROCERA IMPLANT BRIDGE | Oct 16, 2009 | Substantially Equivalent | NOBEL BIOCARE AB |
| K091907 | NOBELPROCERA IMPLANT BRIDGE ZIRCONIA | Oct 06, 2009 | Substantially Equivalent | NOBEL BIOCARE AB |
| K091920 | ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL | Sep 28, 2009 | Substantially Equivalent | ASTRA TECH, INC. |
| K092248 | SPI CUSTOMIZABLE GINGIVA FORMER | Sep 25, 2009 | Substantially Equivalent | THOMMEN MEDICAL, AG |
| K091904 | NOBELPROCERA ZI ABUTMENT | Sep 25, 2009 | Substantially Equivalent | NOBEL BIOCARE AB |
| K091756 | NOBELPROCERA TI ABUTMENT | Sep 22, 2009 | Substantially Equivalent | NOBEL BIOCARE AB |
| K091693 | TDS ZIRCONIA ABUTMENT FOR NOBEL BIOCARE BRANEMARK | Jul 30, 2009 | Substantially Equivalent | POU YU BIOTECHNOLOGY CO., LTD. |
| K091392 | TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK | Jul 30, 2009 | Substantially Equivalent | POU YU BIOTECHNOLOGY CO., LTD. |
| K090976 | VERICORE ABUTMENT IN ZIRCONIA FOR IMPLANT SYSTEMS | Jun 25, 2009 | Substantially Equivalent | WHIP-MIX CORP. |
| K091026 | TDS ABUTMENT FOR NOBEL BIOCARE REPLACE | Jun 24, 2009 | Substantially Equivalent | POU YU BIOTECHNOLOGY CO., LTD. |
| K090347 | CAMLOG ABUTMENTS PS | Jun 18, 2009 | Substantially Equivalent | ALTATEC GMBH |
| K090397 | XPI ANGLED ABUTMENTS | Jun 05, 2009 | Substantially Equivalent | KEYSTONE DENTAL, INC. |
| K090069 | PROCERA IMPLANT BRIDGE OVERDENTURE | May 07, 2009 | Substantially Equivalent | NOBEL BIOCARE AB |
| K083480 | INCLUSIVE ZIRCONIA ABUTMENT BLANKS | May 05, 2009 | Substantially Equivalent | INCLUSIVE DENTAL SOLUTIONS |
| K083871 | ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE | Apr 15, 2009 | Substantially Equivalent | ASTRA TECH, INC. |
| K090723 | HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5, | Apr 07, 2009 | Substantially Equivalent | ZIMMER DENTAL INC. |
| K090153 | SPI VARIOMULTI ANGLED ABUTMENT | Mar 27, 2009 | Substantially Equivalent | THOMMEN MEDICAL, AG |
| K083192 | INCLUSIVE TITANIUM ABUTMENT BLANKS | Mar 04, 2009 | Substantially Equivalent | INCLUSIVE DENTAL SOLUTIONS |
| K081851 | NEOSS ACCESS ABUTMENTS | Mar 02, 2009 | Substantially Equivalent | NEOSS, LTD. |
| K083324 | LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM | Feb 25, 2009 | Substantially Equivalent | ZEST ANCHORS, INC. |
| K083544 | KAT IMPLANT SYSTEM | Feb 02, 2009 | Substantially Equivalent | KAT IMPLANTS, LLC |
| K081396 | SWISSPLANT DENTAL IMPLANT SYSTEM | Jan 14, 2009 | Substantially Equivalent | IMPLANT DIRECT LLC |
| K081101 | SPECTRA-SYSTEM ABUTMENTS 2008 | Jan 14, 2009 | Substantially Equivalent | IMPLANT DIRECT LLC |
| K083474 | ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT | Dec 23, 2008 | Substantially Equivalent | ZIMMER DENTAL INC. |
| K081786 | ZIOCERA & CONVERTIBLE SYSTEM | Dec 02, 2008 | Substantially Equivalent | OSSTEM IMPLANT CO LTD |
| K081460 | TDS ABUTMENT | Nov 21, 2008 | Substantially Equivalent | POU YU BIOTECHNOLOGY CO., LTD. |
| K082299 | VERICORE IMPLANT ABUTMENTS | Nov 20, 2008 | Substantially Equivalent | WHIP-MIX CORP. |
| K083100 | GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP | Nov 19, 2008 | Substantially Equivalent | NOBEL BIOCARE USA, LLC |
| K083141 | SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM | Nov 07, 2008 | Substantially Equivalent | SIMPACT LLC |
| K082545 | STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS | Oct 17, 2008 | Substantially Equivalent | INSTITUT STRAUMANN AG |
| K081666 | ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED 3.0 IMPLANTS | Oct 07, 2008 | Substantially Equivalent | ASTRA TECH, INC. |
| K082764 | STRAUMANN WN CARES TITANIUM ABUTMENT | Oct 01, 2008 | Substantially Equivalent | INSTITUT STRAUMANN AG |
| K080164 | ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT | Sep 25, 2008 | Substantially Equivalent | ZIMMER DENTAL INC. |
| K081575 | HU/HS/HG PROSTHETIC SYSTEM | Sep 02, 2008 | Substantially Equivalent | OSSTEM IMPLANT CO.,LTD |
| K081157 | ACCUFRAME | Jul 22, 2008 | Substantially Equivalent | CAGENIX INC. |
| K080864 | CAM STRUCTSURE PRECISION MILLED BARS | Jul 21, 2008 | Substantially Equivalent | BIOMET 3I, INC. |
| K081186 | CONCAVE RN HEALING CAP | May 23, 2008 | Substantially Equivalent | INSTITUT STRAUMANN AG |
| K080598 | MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS | May 21, 2008 | Substantially Equivalent | INTRA-LOCK INTERNATIONAL |
| K073217 | INCLUSIVE IMPLANT ABUTMENTS | May 14, 2008 | Substantially Equivalent | INCLUSIVE DENTAL SOLUTIONS |
| K080397 | AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM | May 06, 2008 | Substantially Equivalent | AMERICAN DENTAL IMPLANT CORPORATION |
| K081005 | P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS | May 02, 2008 | Substantially Equivalent | INSTITUT STRAUMANN AG |
| K080239 | P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS | Apr 30, 2008 | Substantially Equivalent | STRAUMANN MANUFACTURING, INC. |
| K072730 | FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS | Mar 27, 2008 | Substantially Equivalent | DENTSPLY INTL. |
| K080286 | CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS | Mar 07, 2008 | Substantially Equivalent | STRAUMANN USA |
| K073345 | CERTAIN CONTOURED MARGIN CERAMIC ABUTMENT | Mar 07, 2008 | Substantially Equivalent | BIOMET 3I, INC. |
| K073553 | CAMLOG IMPLANT SYSTEM ABUTMENTS | Mar 05, 2008 | Substantially Equivalent | ALTATEC GMBH |
| K073540 | ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT | Feb 29, 2008 | Substantially Equivalent | ATLANTIS COMPONENTS, INC. |
| K072055 | LAVA FRAME, LAVA FRAME SHADE | Feb 26, 2008 | Substantially Equivalent | 3M ESPE AG DENTAL PRODUCTS |
| K072129 | NOBELACTIVE ZIRCONIA ABUTMENT | Feb 22, 2008 | Substantially Equivalent | NOBEL BIOCARE AB |
| K072856 | SPI VARIOMULTI ABUTMENT | Feb 15, 2008 | Substantially Equivalent | THOMMEN MEDICAL, AG |
| K073258 | ATLANTIS ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI + ABUTMENT | Feb 14, 2008 | Substantially Equivalent | ATLANTIS COMPONENTS, INC. |
| K072100 | GC AADVA ABUTMENT | Feb 14, 2008 | Substantially Equivalent | GC AMERICA, INC. |
| K073073 | ANKYLOS TEMPORARY ABUTMENT BALANCE | Feb 12, 2008 | Substantially Equivalent | DENTSPLY INTERNATIONAL, INC. |
| K073628 | SYNOCTA ABUTMENTS | Jan 22, 2008 | Substantially Equivalent | STRAUMANN USA |
| K072570 | NOBELACTIVE MULTI UNIT ABUTMENT | Dec 28, 2007 | Substantially Equivalent | NOBEL BIOCARE AB |
| K072642 | BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS | Dec 20, 2007 | Substantially Equivalent | BIOMET 3I, INC. |
| K073141 | SPI ART ABUTMENT | Dec 05, 2007 | Substantially Equivalent | THOMMEN MEDICAL, AG |
| K072878 | MODIFICATION TO: LOCATOR IMPLANT ANCHOR | Dec 03, 2007 | Substantially Equivalent | ZEST ANCHORS, INC. |
| K070228 | IMPLANTIUM PROSTHETICS | Nov 20, 2007 | Substantially Equivalent | DENTIUM CO., LTD. |
| K073032 | PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS | Nov 16, 2007 | Substantially Equivalent | LIFECORE BIOMEDICAL, INC. |
| K072483 | ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI ABUTMENT IN ZIRCONIA FOR ASTRA IMPLANTS | Nov 16, 2007 | Substantially Equivalent | ATLANTIS COMPONENTS, INC. |
| K072241 | PRIMACONNEX CAD/CAM ABUTMENT SYSTEM | Nov 09, 2007 | Substantially Equivalent | LIFECORE BIOMEDICAL, INC. |
| K071838 | NEOSS VARIOUS TITANIUM ABUTMENTS | Oct 19, 2007 | Substantially Equivalent | NEOSS LTD |
| K071888 | STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES | Oct 15, 2007 | Substantially Equivalent | STRAUMANN USA |
| K072679 | P.004 ABUTMENTS | Oct 12, 2007 | Substantially Equivalent | INSTITUT STRAUMANN AG |
| K072572 | PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS | Oct 05, 2007 | Substantially Equivalent | LIFECORE BIOMEDICAL, INC. |
| K071946 | ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS | Oct 05, 2007 | Substantially Equivalent | ATLANTIS COMPONENTS, INC. |
| K072624 | ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT | Oct 01, 2007 | Substantially Equivalent | ASTRA TECH AB |
| K072497 | P.004 NC GOLD ABUTMENT FOR CROWNS | Sep 26, 2007 | Substantially Equivalent | INSTITUT STRAUMANN AG |
| K071919 | P.004 ABUTMENTS | Sep 26, 2007 | Substantially Equivalent | STRAUMANN USA (ON BEHALF OF INSTITUT STRAUMANN AG) |
| K071357 | P.004 NC ANATOMIC ABUTMENTS | Sep 26, 2007 | Substantially Equivalent | INSTITUT STRAUMANN AG |
| K070478 | P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP) | Sep 20, 2007 | Substantially Equivalent | STRAUMANN MANUFACTURING, INC. |
| K071453 | SPI EASY 4.0 ABUTMENT | Sep 19, 2007 | Substantially Equivalent | THOMMEN MEDICAL, AG |
| K072151 | P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS | Sep 11, 2007 | Substantially Equivalent | STRAUMANN USA |
| K070549 | STRAUMANN P.004 RC GOLD ABUTMENT | Aug 31, 2007 | Substantially Equivalent | INSTITUT STRAUMANN AG |
| K071551 | QUICKBRIDGE TM CYLINDER AND CAP | Aug 30, 2007 | Substantially Equivalent | BIOMET 3I, INC. |
| K072071 | STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS | Aug 15, 2007 | Substantially Equivalent | INSTITUT STRAUMANN AG |
| K071213 | CAMLOG LOGFIT PROSTHETIC SYSTEM | Aug 10, 2007 | Substantially Equivalent | ALTATEC GMBH |
| K071585 | P.004 HEALING ABUTMENTS AND CLOSURE SCREWS | Jul 11, 2007 | Substantially Equivalent | STRAUMANN USA |
| K070744 | NARROW NECK TEMPORARY COPING | Jun 29, 2007 | Substantially Equivalent | INSTITUT STRAUMANN AG |
| K063768 | TITANIUM SCALLOPED ABUTMENT | Jun 27, 2007 | Substantially Equivalent | VIDENT |
| K070833 | ATLANTIS ABUTMENT FOR ASTRA IMPLANT | Jun 22, 2007 | Substantially Equivalent | ATLANTIS COMPONENTS, INC. |
| K070533 | BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS | Jun 21, 2007 | Substantially Equivalent | B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. |
| K063106 | REVOIS IMPLANT SYSTEM | Jun 11, 2007 | Substantially Equivalent | CURASAN AG |
| K070562 | EZ PLUS IMPLANT SYSTEM | May 18, 2007 | Substantially Equivalent | MEGAGEN CO., LTD. |
| K063789 | WN SYNOCTA GOLD ABUTMENT | May 10, 2007 | Substantially Equivalent | STRAUMANN USA |
| K061277 | STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING | Apr 12, 2007 | Substantially Equivalent | STRAUMANN USA |
| K063403 | CONICAL ANGLED ABUTMENT | Mar 20, 2007 | Substantially Equivalent | IMPLANT INNOVATIONS, INC. |
| K063734 | ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE | Mar 02, 2007 | Substantially Equivalent | ATLANTIS COMPONENTS, INC. |
| K062197 | ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT | Feb 28, 2007 | Substantially Equivalent | ATLANTIS COMPONENTS, INC. |
| K063592 | ADAPTER PS RP-NP, 34551, ADAPTER PS WP-RP,34552, ABUTMENT SCREW PS RP-NP, 34553, ABUTMENT SCREW PS WP-RP, 34554 | Feb 27, 2007 | Substantially Equivalent | NOBEL BIOCARE AB |
| K062069 | ATLANTIS ABUTMENT FOR 3I MICROMINI IMPLANT | Feb 14, 2007 | Substantially Equivalent | ATLANTIS COMPONENTS, INC. |
| K062277 | ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE | Dec 20, 2006 | Substantially Equivalent | ATLANTIS COMPONENTS, INC. |
| K062749 | SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM | Nov 29, 2006 | Substantially Equivalent | NOBEL BIOCARE AB |
| K061567 | BIOHORIZONS CERAMIC ABUTMENT | Nov 22, 2006 | Substantially Equivalent | BIOHORIZONS IMPLANT SYSTEMS, INC. |
| K062493 | LAVA SOFTWARE | Nov 17, 2006 | Substantially Equivalent | 3M ESPE AG DENTAL PRODUCTS |
| K062876 | PRIMACONNEX CERAMIC ABUTMENTS | Nov 01, 2006 | Substantially Equivalent | LIFECORE BIOMEDICAL, INC. |
| K061847 | ZIMMER CONTOUR CERAMIC ABUTMENT, MODELS ZRA341S, ZRA342S, KRA451S, ZRA452S | Oct 12, 2006 | Substantially Equivalent | ZIMMER DENTAL INC. |
| K061529 | PROCERA ZIRCONIA ABUTMENT FOR CAMLOG IMPLANT SYSTEM | Aug 23, 2006 | Substantially Equivalent | NOBEL BIOCARE AB |
| K061478 | PROCERA TITANIUM ABUTMENT FOR ASTRATECH AND CAMLOG IMPLANT SYSTEMS | Aug 21, 2006 | Substantially Equivalent | NOBEL BIOCARE AB |
| K061477 | MULTI-UNIT ABUTMENTS FOR ASTRATECH, CAMLOG AND ANKYLOS IMPLANT SYSTEMS | Aug 11, 2006 | Substantially Equivalent | NOBEL BIOCARE AB |
| K061807 | SPI ART ABUTMENTS | Jul 31, 2006 | Substantially Equivalent | THOMMEN MEDICAL, AG |
| K053654 | ATLANTIS ABUTMENT FOR NOBEL REPLACE INTERFACE | Jul 31, 2006 | Substantially Equivalent | ATLANTIS COMPONENTS, INC. |
| K052957 | IMPLANTIUM PROSTHETICS | Jul 27, 2006 | Substantially Equivalent | DENTIUM CO., LTD. |
| K061969 | PREFORMANCE POSTS AND TEMPORARY CYLINDERS | Jul 21, 2006 | Substantially Equivalent | IMPLANT INNOVATIONS, INC. |
| K053373 | ATLANTIS ABUTMENT FOR ZIMMER INTERFACE | Jun 30, 2006 | Substantially Equivalent | ATLANTIS COMPONENTS, INC. |
| K061043 | ZIMMER CONTOUR RESTORATIVE SYSTEM | Jun 27, 2006 | Substantially Equivalent | ZIMMER DENTAL INC. |
| K060063 | LEGACY ABUTMENT SYSTEM | May 19, 2006 | Substantially Equivalent | IMPLANT DIRECT LLC |
| K060880 | ZIMMER DENTAL ONE PIECE TAPERED ABUTMENT, MODELS TAC1, TACW1, TA5C1 | May 17, 2006 | Substantially Equivalent | ZIMMER DENTAL INC. |
| K061177 | PROVIDE TEMPORARY CYLINDER | May 16, 2006 | Substantially Equivalent | IMPLANT INNOVATIONS, INC. |
| K053450 | ATLANTIS ABUTMENT FOR ZIMMER INTERFACE | Mar 03, 2006 | Substantially Equivalent | ATLANTIS COMPONENTS, INC. |
| K060291 | PREFORMANCE TEMPORARY CYLINDER | Feb 27, 2006 | Substantially Equivalent | IMPLANT INNOVATIONS, INC. |
| K053125 | PROCERA BRIDGE ZIRCONIA | Feb 22, 2006 | Substantially Equivalent | NOBEL BIOCARE AB |
| K053068 | PROCERA BRIDGE LAMINATE, MODEL 40-4002 | Feb 22, 2006 | Substantially Equivalent | NOBEL BIOCARE AB |
| K053050 | PROCERA BRIDGE ALUMINA | Feb 22, 2006 | Substantially Equivalent | NOBEL BIOCARE AB |
| K052823 | IMPLANTIUM ABUTMENTS | Feb 21, 2006 | Substantially Equivalent | DENTIUM, INC. |
| K051636 | CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES | Feb 17, 2006 | Substantially Equivalent | ALTATEC GMBH |
| K053099 | BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS | Feb 14, 2006 | Substantially Equivalent | BIOHORIZONS IMPLANT SYSTEMS, INC. |
| K053602 | PROCERA SOFTWARE, MODEL 33145 | Feb 10, 2006 | Substantially Equivalent | NOBEL BIOCARE AB |
| K053170 | PREFORMANCE POSTS | Feb 01, 2006 | Substantially Equivalent | IMPLANT INNOVATIONS, INC. |
| K053091 | PROCERA IMPLANT BRIDGE ZIRCONIA | Jan 27, 2006 | Substantially Equivalent | NOBEL BIOCARE AB |
| K053643 | STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 | Jan 23, 2006 | Substantially Equivalent | LIFECORE BIOMEDICAL, INC. |
| K052272 | STRAUMANN COMPUTER AIDED RESTORATION SERVICE | Jan 03, 2006 | Substantially Equivalent | STRAUMANN USA |
| K052885 | ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315 | Dec 23, 2005 | Substantially Equivalent | NOBEL BIOCARE USA LLC |
| K052648 | MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS | Oct 20, 2005 | Substantially Equivalent | IMPLANT INNOVATIONS, INC. |
| K051501 | ZIRACE | Oct 19, 2005 | Substantially Equivalent | ACUCERA, INC. |
| K052070 | ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT IN ZIRCONIA, ATLANTIS GEMEINI + ABUTMENT IN ZIRCONIA | Oct 14, 2005 | Substantially Equivalent | ATLANTIS COMPONENTS, INC. |
| K052600 | ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED) | Oct 13, 2005 | Substantially Equivalent | ZIMMER DENTAL INC. |
| K051527 | SPI EASY TEMPORARY CAP | Jul 28, 2005 | Substantially Equivalent | THOMMEN MEDICAL, AG |
| K051652 | ATLANTIS ABUTMENT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI+ ABUTMENT | Jul 22, 2005 | Substantially Equivalent | ATLANTIS COMPONENTS, INC. |
| K051011 | ENDOSSEOUS DENTAL IMPLANT ABUTMENT | Jul 12, 2005 | Substantially Equivalent | ATLANTIS COMPONENTS, INC. |
| K043428 | RELIADENT DENTAL IMPLANT SYSTEM | Jul 12, 2005 | Substantially Equivalent | BIOINFERA, INC. |
| K051717 | RN SYNOCTA TEMPORARY MESO ABUTMENT | Jul 07, 2005 | Substantially Equivalent | INSTITUT STRAUMANN SA |
| K050444 | NOBELREPLACE ADAPTER, MODEL 32412 | Jul 07, 2005 | Substantially Equivalent | NOBEL BIOCARE UAS INC |
| K050208 | FRIADENT ESTHETICAP | Jun 14, 2005 | Substantially Equivalent | DENTSPLY INTERNATIONAL |
| K050641 | ZYGOMA TIUNITE | Apr 07, 2005 | Substantially Equivalent | NOBEL BIOCARE USA LLC |
| K042715 | TITAN DENTAL IMPLANT ATTACHMENT | Mar 23, 2005 | Substantially Equivalent | TITAN IMPLANTS, INC. |
| K050052 | ATLANTIS ABUTMENT FOR STRAUMANN INTERFACE | Mar 07, 2005 | Substantially Equivalent | ATLANTIS COMPONENTS, INC. |
| K043190 | SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM | Dec 14, 2004 | Substantially Equivalent | INNOVA LIFE SCIENCES CORP. |
| K042466 | X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE | Nov 24, 2004 | Substantially Equivalent | ZEST ANCHORS, INC. |
| K043042 | PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052 | Nov 18, 2004 | Substantially Equivalent | NOBEL BIOCARE AB |
| K042658 | PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 | Oct 20, 2004 | Substantially Equivalent | NOBEL BIOCARE UAS INC |
| K041070 | STRAUMANN TEMPORARY COPING | Jul 23, 2004 | Substantially Equivalent | THE STRAUMANN CO. |
| K041275 | PROCERA ABUTMENT OCTAGON | May 27, 2004 | Substantially Equivalent | NOBEL BIOCARE UAS INC |
| K041236 | PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052 | May 26, 2004 | Substantially Equivalent | NOBEL BIOCARE AB |
| K041295 | RN SYNOCTA UCLA GOLD ABUTMENT FOR THE STRAUMANN DENTAL IMPLANT | May 24, 2004 | Substantially Equivalent | INSTITUT STRAUMANN AG |
| K040573 | NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236 | Apr 28, 2004 | Substantially Equivalent | NOBEL BIOCARE UAS INC |
| K034035 | 3I PATIENT-SPECIFIC OVERDENTURE BAR | Mar 24, 2004 | Substantially Equivalent | IMPLANT INNOVATIONS, INC. |
| K040205 | INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTS | Mar 22, 2004 | Substantially Equivalent | INTRA-LOCK INTERNATIONAL |
| K040539 | ELLIPTIC MATRIX | Mar 18, 2004 | Substantially Equivalent | INSTITUT STRAUMANN AG |
| K033724 | NOBEL BIOCARE CENTRIC POST, MODELS 31234, 31235 AND 31236 | Feb 23, 2004 | Substantially Equivalent | NOBEL BIOCARE UAS INC |
| K033346 | SPI EASY DENTAL IMPLANT PROTECTIVE CAP | Nov 03, 2003 | Substantially Equivalent | THOMMEN MEDICAL, AG |
| K033243 | ITI SYNOCTA MESO ABUTMENTS | Oct 20, 2003 | Substantially Equivalent | STRAUMANN USA |
| K032498 | DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM) | Aug 27, 2003 | Substantially Equivalent | STRAUMANN USA |
| K032448 | ALTATEC CERAMIC ABUTMENT | Aug 22, 2003 | Substantially Equivalent | ALTATEC BIOTECHNOLOGIES |
| K031747 | SPI DENTAL IMPLANT ABUTMENTS | Jul 02, 2003 | Substantially Equivalent | THOMMEN MEDICAL, AG |
| K031719 | ESTHETIC ZIRCONIA ABUTMENT | Jul 02, 2003 | Substantially Equivalent | NOBEL BIOCARE AB |
| K023645 | SPI EASY DENTAL IMPLANT ABUTMENT | Nov 13, 2002 | Substantially Equivalent | THOMMEN MEDICAL, AG |
| K023631 | ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS | Nov 07, 2002 | Substantially Equivalent | ASTRA TECH, INC. |
| K022795 | MODIFICATION TO THE MAESTRO SYSTEM | Aug 30, 2002 | Substantially Equivalent | BIOHORIZONS IMPLANT SYSTEMS, INC. |
| K021460 | OCO DENTAL IMPLANT | May 22, 2002 | Substantially Equivalent | O CO., INC. |
| K014175 | SULZER DENTAL CERAMIC SYSTEM-HEXLOCK | Mar 20, 2002 | Substantially Equivalent | SULZER DENTAL, INC. |
| K974150 | PROCERA PREPARABLE ABUTMENT SYSTEM | Jan 23, 1998 | Substantially Equivalent | NOBEL BIOCARE UAS INC |
| K972475 | AURADAPT AUBTMENT SYSTEM | Sep 12, 1997 | Substantially Equivalent | NOBEL BIOCARE UAS INC |
| K971706 | TIADAPT ABUTMENT SYSTEM | Jul 21, 1997 | Substantially Equivalent | NOBEL BIOCARE UAS INC |
| K970073 | BIO-ESTHETIC INDIRECT ABUTMENT | Jul 03, 1997 | Substantially Equivalent | STERI-OSS, INC. |
| K961736 | 17 ANGULATED ABUTMENT | Jul 18, 1996 | Substantially Equivalent | NOBELPHARMA USA, INC. |
| K961728 | MIRUSCONE ABUTMENT SYSTEM | Jul 10, 1996 | Substantially Equivalent | NOBELPHARMA USA, INC. |
| K925349 | ONE SYSTEM TAPERED TITANIUM ABUTMENTS | Jul 27, 1993 | Substantially Equivalent | IMPLANT SUPPORT SYSTEMS, INC. |
| K925779 | BRANEMARK SYSTEM TITANIUM HEALING ABUTMENTS | Apr 20, 1993 | Substantially Equivalent | NOBELPHARMA USA, INC. |
| K925769 | BRANEMARK SYSTEM ABUTMENTS COMPLETE | Apr 14, 1993 | Substantially Equivalent | NOBELPHARMA USA, INC. |
FEI Numbers
This FDA classification entry is associated with 390 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 390 registration numbers. Click on an entry to view related FDA registrations.