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 |
|---|---|---|---|
| Feb 20, 2024 | K233194 | TS Abutment System Osstem Implant Co., Ltd., KR | NHA |
| Jan 24, 2024 | K233208 | NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium Nobel Biocare AB, SE | NHA |
| Jan 22, 2024 | K233450 | MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Ca Megagen Implant Co., Ltd., KR | NHA |
| Jan 12, 2024 | K232170 | Ti Link Abutment Izenimplant Co., Ltd., KR | NHA |
| Jan 5, 2024 | K233316 | DESS Dental Smart Solutions Terrats Medical SL, ES | NHA |
| Jan 4, 2024 | K231072 | Anthogyr FlexiBase® titanium bases for Axiom® BL Anthogyr, FR | NHA |
| Dec 21, 2023 | K231307 | Elos Accurate Customized Abutment Elos Medtech Pinol A/S, DK | NHA |
| Dec 20, 2023 | K231411 | INNO SLA Submerged Hybrid Ti-Base System Cowellmedi Co., Ltd., KR | NHA |
| Dec 19, 2023 | K232560 | Angled Abutment Arum Dentistry Co., Ltd., KR | NHA |
| Dec 13, 2023 | K231803 | Neodent Implant System - Zirconia Implant System JJGC Indústria e Comércio de Materiais Dentários S.A., BR | NHA |
| Dec 8, 2023 | K232750 | BTI Interna Prosthetic Components B.T.I. Biotechnology Institute, Sl., ES | NHA |
| Dec 5, 2023 | K232220 | SS Abutment System Osstem Implant Co., Ltd., KR | NHA |
| Nov 21, 2023 | K232546 | Meta G UCLA Abutment Cowellmedi Co., Ltd., KR | NHA |
| Nov 17, 2023 | K231559 | Multi-Unit DAS System Talladium España, SL, ES | NHA |
| Nov 14, 2023 | K231097 | Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer Prismatik Dentalcraft, Inc. | NHA |
| Oct 30, 2023 | K231874 | AOT & T-L Abutment Truabutment, Inc. | NHA |
| Oct 26, 2023 | K232271 | SIMDA abutment Simda Co., Ltd., KR | NHA |
| Oct 17, 2023 | K232151 | Dynamic TiBase Talladium España, SL, ES | NHA |
| Oct 10, 2023 | K231413 | IPD Dental Implant Abutments Implant Protesis Dental 2004, S.L., ES | NHA |
| Oct 2, 2023 | K221972 | Warantec Custom Abutment Warantec Co., Ltd., KR | NHA |
| Sep 26, 2023 | K223496 | Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Prismatik Dentalcraft, Inc. | NHA |
| Sep 15, 2023 | K231827 | BTI Dental Implant System UnicCa® Aesthetic Post Abutments B.T.I. Biotechnology Institute, Sl., ES | NHA |
| Sep 15, 2023 | K231235 | LW UCLA Abutment Ossvis Co., Ltd., KR | NHA |
| Sep 14, 2023 | K231079 | LW Retraction Cap Ossvis Co., Ltd., KR | NHA |
| Sep 1, 2023 | K230317 | Elos Accurate Hybrid Base Elos Medtech Pinol A/S, DK | NHA |
| Aug 24, 2023 | K231557 | ZENEX FreeMilling & CCM Cast Abutment Izenimplant Co., Ltd., KR | NHA |
| Aug 18, 2023 | K220253 | Eco Abutment, Multiunit Abutment Dio Corporation, KR | NHA |
| Aug 15, 2023 | K231455 | Implant-One System Implant Logistics, Inc. | NHA |
| Aug 14, 2023 | K231434 | DESS Dental Smart Solutions Terrats Medical SL, ES | NHA |
| Aug 4, 2023 | K230126 | Dentis s-Clean Regular Abutment Dentis Co., Ltd., KR | NHA |
| Aug 1, 2023 | K230873 | Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments Southern Implants (Pty), Ltd., ZA | NHA |
| Jul 14, 2023 | K222026 | Neodent Implant System - Zirconia Implant System Jjgc Industria E Comercio DE Materiais Dentarios S.A., BR | NHA |
| Jul 14, 2023 | K221673 | Bonafix TiBase Zentek Medical, LLC | NHA |
| Jul 11, 2023 | K230307 | Dentis i-Clean System Dentis Co., Ltd., KR | NHA |
| Jun 20, 2023 | K223535 | SMARTbase Abutment System Implant Direct Sybron Manufacturing, LLC | NHA |
| May 25, 2023 | K230246 | Dentis s-Clean SQ-SL Narrow Implant System Dentis Co., Ltd., KR | NHA |
| May 24, 2023 | K230523 | s-Clean Link Abutment Narrow Dentis Co., Ltd., KR | NHA |
| May 24, 2023 | K223663 | SIMDA Abutment Simda Co., Ltd., KR | NHA |
| May 15, 2023 | K222836 | Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs Institut Straumann AG, CH | NHA |
| May 12, 2023 | K221969 | IU Implant System Abutment Warantec Co., Ltd., KR | NHA |
| May 3, 2023 | K230203 | Dentis I-FIX Abutment Dentis Co., Ltd., KR | NHA |
| Apr 28, 2023 | K223677 | Titanium Abutment Blank Nobel Biocare N1 TCC Nobel Biocare AB, SE | NHA |
| Apr 28, 2023 | K223634 | Customized Abutment Arum Dentistry Co., Ltd., KR | NHA |
| Apr 28, 2023 | K222636 | ET Abutment System Hiossen, Inc. | NHA |
| Apr 25, 2023 | K230218 | DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) Dental Direkt GmbH, DE | NHA |
| Apr 24, 2023 | K230103 | Klockner Abutments SOADCO, S.L., AD | NHA |
| Apr 17, 2023 | K222469 | TIB Abutments Southern Implants (Pty), Ltd., ZA | NHA |
| Apr 13, 2023 | K230143 | DESS Dental Smart Solutions Terrats Medical SL, ES | NHA |
| Apr 6, 2023 | K230069 | S.I.N. Dental Implant System S.I.N. Sistema DE Implante Nacional S.A., BR | NHA |
| Mar 23, 2023 | K212394 | Implant-One Multi-Unit Abutment Implant Logistics, Inc. | NHA |
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