Abutment, Implant, Dental, Endosseous
Regulation 872.3630
30510(k)s in 12 months (716 all time)
5recalls in 12 months (225 all time)
194recalls that name a 510(k)
Top companies in NHA
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomet 3i | 19 | 174 |
| Nobel Biocare AB | 49 | 7 |
| Institut Straumann AG | 47 | 0 |
| Straumann USA | 32 | 7 |
| Dentsply Sirona | 23 | 0 |
| Terrats Medical SL | 21 | 0 |
| Zimmer Dental, Inc. | 21 | 0 |
| Prismatik Dentalcraft, Inc. | 19 | 1 |
| Osstem Implant Co., Ltd. | 18 | 0 |
| Atlantis Components, Inc. | 17 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 30, 2026 | K261327 | Elos Accurate Hybrid Base Elos Medtech Pinol A/S, DK | NHA |
| Sep 23, 2026 | K262207 | Cemented Plus Abutment Unidental Co., Ltd., KR | NHA |
| Sep 21, 2026 | K260940 | BellaTek Bars ZimVie US Corp, LLC | NHA |
| Aug 6, 2026 | K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and No Nobel Biocare AB, SE | NHA |
| Jul 1, 2026 | K261147 | Neodent Implant System - NeoConvert Fit JJGC Indústria e Comércio de Materiais Dentários S.A., BR | NHA |
| Jun 27, 2026 | K261122 | MIST IC Imagine Milling Technologies, LLC | NHA |
| Jun 26, 2026 | K260061 | BioHorizons CEREC Compatible Ti-Bases BioHorizons Implant Systems, Inc. | NHA |
| Jun 15, 2026 | K253922 | Neodent Scannable Healing Abutment JJGC Indústria e Comércio de Materiais Dentários S.A. | NHA |
| Jun 11, 2026 | K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut) Smart Denture Conversions, LLC | NHA |
| Jun 9, 2026 | K260564 | DESS Dental Smart Solutions Terrats Medical SL, ES | NHA |
| Jun 3, 2026 | K252904 | SIC Abutments including CAD/CAM Solutions Sic Invent AG, CH | NHA |
| May 20, 2026 | K253774 | Elos Accurate® Denture Fixation System Elos Medtech Pinol A/S, DK | NHA |
| May 14, 2026 | K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments Hiossen, Inc. | NHA |
| May 7, 2026 | K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue Institut Straumann AG, CH | NHA |
| Apr 16, 2026 | K253804 | DESS Dental Smart Solutions Terrats Medical SL, ES | NHA |
| Apr 9, 2026 | K260555 | LOCATOR® Angled Abutment Zest Anchors, LLC | NHA |
| Mar 4, 2026 | K251434 | Healing Abutment System Osstem Implant Co., Ltd., KR | NHA |
| Feb 10, 2026 | K251515 | Solidex® Ti-Links and Screws CreoDent Hudson Valley | NHA |
| Jan 29, 2026 | K251427 | EK MULTI ANGLED 30 ABUTMENT Hiossen, Inc. | NHA |
| Jan 29, 2026 | K243732 | Multi-Unit DAS System Talladium España, SL, ES | NHA |
| Jan 22, 2026 | K253315 | Straumann Variobase Abutments XC for Bridge/Bar Institut Straumann AG, CH | NHA |
| Jan 22, 2026 | K253253 | IPDmilled Blanks Implant Protesis Dental 2004, S.L., ES | NHA |
| Jan 7, 2026 | K252727 | Neodent InLab Validated Workflow JJGC Indústria e Comércio de Materiais Dentários S.A., BR | NHA |
| Dec 23, 2025 | K253341 | Custom Abutments AS Medentika GmbH, DE | NHA |
| Dec 23, 2025 | K253312 | OrangeCAD Med Abutments Orangecad Med GmbH, DE | NHA |
| Dec 18, 2025 | K252320 | SIMDA Abutments Simda Co., Ltd., KR | NHA |
| Dec 9, 2025 | K252343 | Atlantis® Abutments in Titanium Dentsply Sirona | NHA |
| Nov 26, 2025 | K252248 | CEREC Tessera Abutment System Dentsply Sirona | NHA |
| Nov 21, 2025 | K251205 | Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants Dentsply Sirona | NHA |
| Nov 18, 2025 | K252582 | Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems Prismatik Dentalcraft, Inc. | NHA |
| Oct 31, 2025 | K251547 | DESS Dental Smart Solutions Terrats Medical SL, ES | NHA |
| Oct 23, 2025 | K252384 | DESS® Dental Smart Solutions Terrats Medical SL, ES | NHA |
| Oct 17, 2025 | K252266 | S.I.N. Dental Implant System S.I.N. Implant System Ltda, BR | NHA |
| Oct 17, 2025 | K250178 | Adin Customized Abutments Adin Dental Implant Systems , Ltd., IL | NHA |
| Oct 16, 2025 | K251497 | Elos Accurate Hybrid Base Elos Medtech Pinol A/S, DK | NHA |
| Oct 15, 2025 | K252944 | LOCATOR® Angled Abutment Zest Anchors, LLC | NHA |
| Oct 15, 2025 | K251294 | Bonafix Implant Abutments Zentek Medical, LLC | NHA |
| Sep 16, 2025 | K242287 | SFIT Abutment Cowellmedi Co., Ltd., KR | NHA |
| Sep 2, 2025 | K242768 | Customized Abutment and Screw Chengdu Besmile Medical Technology Co., Ltd., CN | NHA |
| Aug 20, 2025 | K251471 | IPD Dental Implant Abutments Implant Protesis Dental 2004, S.L., ES | NHA |
| Aug 20, 2025 | K250721 | LOCATOR® Angled Abutment Zest Anchors, LLC | NHA |
| Jul 28, 2025 | K251220 | NUVENTUS NV.C Prosthetic Components Infinitum Eta, Ltd., IL | NHA |
| Jul 28, 2025 | K241183 | ISO Abutment Seum Medi Co., Ltd., KR | NHA |
| Jun 26, 2025 | K250967 | Sherlock Open Implants, LLC | NHA |
| Jun 24, 2025 | K243009 | MIST IC Imagine Milling Technologies, LLC | NHA |
| Jun 16, 2025 | K242978 | Geo Abutment Geomedi Co,., Ltd., KR | NHA |
| May 30, 2025 | K243530 | Dynamic TiBase Talladium España, SL, ES | NHA |
| May 27, 2025 | K250614 | Neodent Implant System - Custom Abutments Jjgc Indústria E Comércia DE Materiais Dentários S.A., BR | NHA |
| May 22, 2025 | K250639 | DESS Dental Smart Solutions Terrats Medical SL, ES | NHA |
| May 8, 2025 | K243824 | Preat Abutments Preat Corporation | NHA |
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