Product code NHA
- Device name
- Abutment, Implant, Dental, Endosseous
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.3630
- Review panel
- DE
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261327 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 2026-09-30 |
| K262207 | Cemented Plus Abutment | Unidental Co., Ltd. | 2026-09-23 |
| K260940 | BellaTek Bars | ZimVie US Corp, LLC | 2026-09-21 |
| K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw | Nobel Biocare AB | 2026-08-06 |
| K261147 | Neodent Implant System - NeoConvert Fit | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-07-01 |
| K261122 | MIST IC | Imagine Milling Technologies, LLC | 2026-06-27 |
| K260061 | BioHorizons CEREC Compatible Ti-Bases | BioHorizons Implant Systems, Inc. | 2026-06-26 |
| K253922 | Neodent Scannable Healing Abutment | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-06-15 |
| K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) | Smart Denture Conversions, LLC | 2026-06-11 |
| K260564 | DESS Dental Smart Solutions | Terrats Medical SL | 2026-06-09 |
| K252904 | SIC Abutments including CAD/CAM Solutions | Sic Invent AG | 2026-06-03 |
| K253774 | Elos Accurate® Denture Fixation System | Elos Medtech Pinol A/S | 2026-05-20 |
| K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments | Hiossen, Inc. | 2026-05-14 |
| K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue | Institut Straumann AG | 2026-05-07 |
| K253804 | DESS Dental Smart Solutions | Terrats Medical SL | 2026-04-16 |
| K260555 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 2026-04-09 |
| K251434 | Healing Abutment System | Osstem Implant Co., Ltd. | 2026-03-04 |
| K251515 | Solidex® Ti-Links and Screws | CreoDent Hudson Valley | 2026-02-10 |
| K243732 | Multi-Unit DAS System | Talladium España, SL | 2026-01-29 |
| K251427 | EK MULTI ANGLED 30 ABUTMENT | Hiossen, Inc. | 2026-01-29 |
| K253253 | IPDmilled Blanks | Implant Protesis Dental 2004, S.L. | 2026-01-22 |
| K253315 | Straumann Variobase Abutments XC for Bridge/Bar | Institut Straumann AG | 2026-01-22 |
| K252727 | Neodent InLab Validated Workflow | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-01-07 |
| K253312 | OrangeCAD Med Abutments | Orangecad Med GmbH | 2025-12-23 |
| K253341 | Custom Abutments AS | Medentika GmbH | 2025-12-23 |
| K252320 | SIMDA Abutments | Simda Co., Ltd. | 2025-12-18 |
| K252343 | Atlantis® Abutments in Titanium | Dentsply Sirona | 2025-12-09 |
| K252248 | CEREC Tessera Abutment System | Dentsply Sirona | 2025-11-26 |
| K251205 | Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants | Dentsply Sirona | 2025-11-21 |
| K252582 | Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems | Prismatik Dentalcraft, Inc. | 2025-11-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10841307135913 | Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 3.0mmL Collar | IMPLANT DIRECT SYBRON MANUFACTURING LLC | 2026-10-20 |
| 10841307136057 | Legacy™ DIRECTarch™ 3.5mmD Platform 17° MUA 2.0mmL Collar | IMPLANT DIRECT SYBRON MANUFACTURING LLC | 2026-10-20 |
| 10841307136040 | Legacy™ DIRECTarch™ 3.5mmD Platform 17° MUA 1.0mmL Collar | IMPLANT DIRECT SYBRON MANUFACTURING LLC | 2026-10-20 |
| 10841307136033 | Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 5.0mmL Collar | IMPLANT DIRECT SYBRON MANUFACTURING LLC | 2026-10-20 |
| 10841307136026 | Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 4.0mmL Collar | IMPLANT DIRECT SYBRON MANUFACTURING LLC | 2026-10-20 |
| 10841307136019 | Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 3.0mmL Collar | IMPLANT DIRECT SYBRON MANUFACTURING LLC | 2026-10-20 |
| 10841307136002 | Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 2.0mmL Collar | IMPLANT DIRECT SYBRON MANUFACTURING LLC | 2026-10-20 |
| 10841307135999 | Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 1.0mmL Collar | IMPLANT DIRECT SYBRON MANUFACTURING LLC | 2026-10-20 |
| 10841307135982 | Legacy™ DIRECTarch™ 3.5 MUA Replacement Screw | IMPLANT DIRECT SYBRON MANUFACTURING LLC | 2026-10-20 |
| 10841307135975 | Legacy™ DIRECTarch™ 3.0mmD Platform 30° MUA 2.0mmL Collar | IMPLANT DIRECT SYBRON MANUFACTURING LLC | 2026-10-20 |
| 10841307135968 | Legacy™ DIRECTarch™ 3.0mmD Platform 30° MUA 1.0mmL Collar | IMPLANT DIRECT SYBRON MANUFACTURING LLC | 2026-10-20 |
| 10841307135951 | Legacy™ DIRECTarch™ 3.0mmD Platform 17° MUA 2.0mmL Collar | IMPLANT DIRECT SYBRON MANUFACTURING LLC | 2026-10-20 |
| 10841307135944 | Legacy™ DIRECTarch™ 3.0mmD Platform 17° MUA 1.0mmL Collar | IMPLANT DIRECT SYBRON MANUFACTURING LLC | 2026-10-20 |
| 10841307135937 | Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 5.0mmL Collar | IMPLANT DIRECT SYBRON MANUFACTURING LLC | 2026-10-20 |
| 10841307135920 | Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 4.0mmL Collar | IMPLANT DIRECT SYBRON MANUFACTURING LLC | 2026-10-20 |
| 08800096849406 | 8plant Implant System | 8dent Inc. | 2026-10-20 |
| 10841307135906 | Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 2.0mmL Collar | IMPLANT DIRECT SYBRON MANUFACTURING LLC | 2026-10-20 |
| 10841307135890 | Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 1.0mmL Collar | IMPLANT DIRECT SYBRON MANUFACTURING LLC | 2026-10-20 |
| 10841307135883 | Legacy™ DIRECTarch™ 3.0 MUA Replacement Screw | IMPLANT DIRECT SYBRON MANUFACTURING LLC | 2026-10-20 |
| 08800096878239 | 8plant Implant System | 8dent Inc. | 2026-10-20 |
| 08800096864577 | 8plant Implant System | 8dent Inc. | 2026-10-20 |
| 08800096864287 | 8plant Implant System | 8dent Inc. | 2026-10-20 |
| 08800096862177 | 8plant Implant System | 8dent Inc. | 2026-10-20 |
| 08800096862160 | 8plant Implant System | 8dent Inc. | 2026-10-20 |
| 08800096861156 | 8plant Implant System | 8dent Inc. | 2026-10-20 |
| 08800096851577 | 8plant Implant System | 8dent Inc. | 2026-10-20 |
| 08800096851485 | 8plant Implant System | 8dent Inc. | 2026-10-20 |
| 08800096851478 | 8plant Implant System | 8dent Inc. | 2026-10-20 |
| 08800096851461 | 8plant Implant System | 8dent Inc. | 2026-10-20 |
| 08800096849833 | 8plant Implant System | 8dent Inc. | 2026-10-20 |