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 |
|---|---|---|---|
| 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 |
| K253315 | Straumann Variobase Abutments XC for Bridge/Bar | Institut Straumann AG | 2026-01-22 |
| K253253 | IPDmilled Blanks | Implant Protesis Dental 2004, S.L. | 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 |
| K251471 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | 2025-08-20 |
| K250721 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 2025-08-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08435389830764 | MULTI-IM® HEALING CAP, TINY® & UNIVERSAL PLATFORM L:3 mm | BIOTECHNOLOGY INSTITUTE SL | 2026-05-27 |
| EMKA03117ET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-12 |
| EMKA10503ET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-12 |
| EMKA20503ET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-12 |
| EMKA40503ET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-12 |
| EMKAB80TET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKA851530ET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKABS80PSET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKABS80TET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKABS81PSET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKABS82PSET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKABS83PSET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKAC80ET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKAC80TET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKAC81ET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKAC81TET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKAC82ET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKAC82TET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKAB80ET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKA8515TET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKA851517ET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKA8509ET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKA80ET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKA40502ET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKA20502ET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKA10502ET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKA03115ET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKA03114ET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKA03110ET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |
| EMKA02821ET9 | MEDENTiKA | MEDENTiKA GmbH | 2019-06-11 |