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 |
|---|---|---|---|
| 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 |
| K251427 | EK MULTI ANGLED 30 ABUTMENT | Hiossen, Inc. | 2026-01-29 |
| K243732 | Multi-Unit DAS System | Talladium España, SL | 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 |
| K253341 | Custom Abutments AS | Medentika GmbH | 2025-12-23 |
| K253312 | OrangeCAD Med Abutments | Orangecad Med 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 |
| K251547 | DESS Dental Smart Solutions | Terrats Medical SL | 2025-10-31 |
| K252384 | DESS® Dental Smart Solutions | Terrats Medical SL | 2025-10-23 |
| K252266 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | 2025-10-17 |
| K250178 | Adin Customized Abutments | Adin Dental Implant Systems , Ltd. | 2025-10-17 |
| K251497 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 2025-10-16 |
| K252944 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 2025-10-15 |
| K251294 | Bonafix Implant Abutments | Zentek Medical, LLC | 2025-10-15 |
| K242287 | SFIT Abutment | Cowellmedi Co., Ltd. | 2025-09-16 |
| K242768 | Customized Abutment and Screw | Chengdu Besmile Medical Technology Co., Ltd. | 2025-09-02 |
| K250721 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 2025-08-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00842092174999 | Preat | Preat Corporation | 2026-06-09 |
| 00842092170199 | Preat | Preat Corporation | 2026-06-09 |
| 08806388211593 | Comfort Cap | Megagen Implant Co. Ltd | 2015-06-24 |
| 08806388211586 | Comfort Cap | Megagen Implant Co. Ltd | 2015-06-24 |
| 08806388211579 | Comfort Cap | Megagen Implant Co. Ltd | 2015-06-24 |
| 08806388211562 | Comfort Cap | Megagen Implant Co. Ltd | 2015-06-24 |
| 08806388211555 | Comfort Cap | Megagen Implant Co. Ltd | 2015-06-24 |
| 08806388211548 | Comfort Cap | Megagen Implant Co. Ltd | 2015-06-24 |
| 08806388211531 | Comfort Cap | Megagen Implant Co. Ltd | 2015-06-24 |
| 08806388211524 | Comfort Cap | Megagen Implant Co. Ltd | 2015-06-24 |
| 08806388211517 | Comfort Cap | Megagen Implant Co. Ltd | 2015-06-24 |
| 08806388211470 | CCM Abutment | Megagen Implant Co. Ltd | 2015-06-24 |
| 08806388211463 | CCM Abutment | Megagen Implant Co. Ltd | 2015-06-24 |
| 08806388211456 | Burn-Out Cylinder | Megagen Implant Co. Ltd | 2015-06-24 |
| 08806388211449 | Burn-Out Cylinder | Megagen Implant Co. Ltd | 2015-06-24 |
| 08806388211432 | Burn-Out Cylinder | Megagen Implant Co. Ltd | 2015-06-24 |
| 08806388211425 | Burn-Out Cylinder | Megagen Implant Co. Ltd | 2015-06-24 |
| 08806388211418 | Burn-Out Cylinder | Megagen Implant Co. Ltd | 2015-06-24 |
| 08806388211395 | Burn-Out Cylinder | Megagen Implant Co. Ltd | 2015-06-24 |
| 08806388211388 | Burn-Out Cylinder | Megagen Implant Co. Ltd | 2015-06-24 |
| 08806388211371 | Ball Abutment | Megagen Implant Co. Ltd | 2015-06-24 |
| 08806388211364 | Ball Abutment | Megagen Implant Co. Ltd | 2015-06-24 |
| 08806388211357 | Ball Abutment | Megagen Implant Co. Ltd | 2015-06-24 |
| 08806388211340 | Ball Abutment | Megagen Implant Co. Ltd | 2015-06-24 |
| 08806388201204 | CCM Cylinder | Megagen Implant Co. Ltd | 2015-06-23 |
| 08806388201198 | CCM Cylinder | Megagen Implant Co. Ltd | 2015-06-23 |
| 08806388201181 | CCM Cylinder | Megagen Implant Co. Ltd | 2015-06-23 |
| 08806388201174 | CCM Cylinder | Megagen Implant Co. Ltd | 2015-06-23 |
| 08806388201167 | CCM Cylinder | Megagen Implant Co. Ltd | 2015-06-23 |
| 08806388201150 | CCM Cylinder | Megagen Implant Co. Ltd | 2015-06-23 |