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 |
|---|---|---|---|
| Mar 22, 2023 | K221402 | CEREC Tessera Abutment Block, CEREC Tessera Abutment System Dentsply Sirona, Inc. | NHA |
| Mar 9, 2023 | K221301 | DESS Dental Smart Solutions Terrats Medical SL, ES | NHA |
| Feb 7, 2023 | K222451 | SAVE GBR Dentis Co., Ltd., KR | NHA |
| Feb 3, 2023 | K223395 | Luna Dental Implant System Shinhung Mst Co., Ltd., KR | NHA |
| Jan 13, 2023 | K222913 | s-Clean Link Abutment Dentis Co., Ltd., KR | NHA |
| Jan 12, 2023 | K222976 | MU System Dentis Co., Ltd., KR | NHA |
| Jan 11, 2023 | K191111 | DD Solid Connect® CAD/CAM Abutments Dental Direkt GmbH, DE | NHA |
| Dec 29, 2022 | K222984 | BioClean Implant Restorative System Bioclean Dental, LLC | NHA |
| Dec 2, 2022 | K220390 | CreoDent Solidex Customized Abutment and Screw Creodent Prosthetics, Ltd. | NHA |
| Dec 1, 2022 | K222368 | MIST IC Imagine Milling Technologies, LLC | NHA |
| Nov 30, 2022 | K222044 | Elos Accurate Customized Abutment Elos Medtech Pinol A/S, DK | NHA |
| Nov 10, 2022 | K220562 | TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment Megagen Implant Co., Ltd., KR | NHA |
| Oct 27, 2022 | K222288 | DESS Dental Smart Solutions Terrats Medical SL, ES | NHA |
| Oct 26, 2022 | K222269 | DESS Dental Smart Solutions Terrats Medical SL, ES | NHA |
| Oct 26, 2022 | K220823 | Preat Abutments Preat Corporation | NHA |
| Oct 21, 2022 | K222215 | IPD Dental Implant Abutments Implant Protesis Dental 2004, S.L., ES | NHA |
| Oct 20, 2022 | K213106 | BTI Interna Dental Implant System UnicCa - Prosthetic Components B.T.I. Biotechnology Institute, Sl., ES | NHA |
| Sep 23, 2022 | K202144 | A.B. Dental Devices Dental Implants System A.B. Dental Device , Ltd., IL | NHA |
| Sep 16, 2022 | K220339 | Esthetic Abutments Nobel Biocare N1 Nobel Biocare Services AG, CH | NHA |
| Sep 15, 2022 | K221966 | Dynamic TiBase Talladium Espana, SL, ES | NHA |
| Sep 8, 2022 | K221684 | Osstem Abutment System Osstem Implant Co., Ltd., KR | NHA |
| Aug 10, 2022 | K221381 | KDG Abutments Keystone Dental, Inc. | NHA |
| Jul 29, 2022 | K220048 | NobelProcera Zirconia N1 Base Nobel Biocare Services AG, CH | NHA |
| Jul 14, 2022 | K213961 | TruAbutment DS, TruBase Truabutment, Inc. | NHA |
| Jul 5, 2022 | K221019 | Osteon Precision Milled Suprastructure Implant Solutions Pty Ltd (Aka Osteon Medical), AU | NHA |
| Jun 21, 2022 | K220482 | Sherlock Open Implants, LLC | NHA |
| Jun 16, 2022 | K220878 | Straumann TLX Variobase C Institut Straumann AG, CH | NHA |
| Jun 16, 2022 | K220440 | Dentis s-Clean Abutment Mini Dentis Co., Ltd., KR | NHA |
| Jun 6, 2022 | K220612 | PrimeLOC Attachment System Innovative Product Brands, Inc. | NHA |
| Jun 2, 2022 | K220751 | Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA Institut Straumann AG, CH | NHA |
| May 17, 2022 | K211396 | Neoss Individual Prosthetics Neoss, Ltd., GB | NHA |
| Apr 14, 2022 | K220252 | High Retention Attachment System Zest Anchors, LLC | NHA |
| Apr 8, 2022 | K213063 | TLX SRAs and TLX Gold Abutments Institut Straumann AG, CH | NHA |
| Apr 1, 2022 | K213432 | MIS Angulated multi-unit abutments Dentsply Sirona | NHA |
| Mar 11, 2022 | K212628 | DESS Dental Smart Solutions Terrats Medical SL, ES | NHA |
| Mar 3, 2022 | K212676 | Osteon Precision Milled Suprastructure Implant Solutions Pty Ltd (Osteon Medical), AU | NHA |
| Feb 4, 2022 | K210356 | Noris Medical Dental Implants System Noris Medical , Ltd., IL | NHA |
| Feb 3, 2022 | K210826 | Healing Abutment, Cover Screw Megagen Implant Co., Ltd., KR | NHA |
| Jan 25, 2022 | K201323 | INNO SLA Submerged Implant System Cowellmedi Co., Ltd., KR | NHA |
| Jan 11, 2022 | K213391 | High Retention Attachment System Zest Anchors, LLC | NHA |
| Dec 21, 2021 | K212730 | BellaTek Encode Emergence Healing Abutments Biomet 3i, LLC | NHA |
| Dec 10, 2021 | K212577 | DESS Dental Smart Solutions Terrats Medical SL, ES | NHA |
| Nov 30, 2021 | K212664 | Sherlock Open Implants, LLC | NHA |
| Nov 18, 2021 | K211871 | FAICO Dental Implant System and CAD/CAM Abutments Faico Medical, LLC | NHA |
| Nov 15, 2021 | K213449 | DS Implants abutments provided with the EV connection Dentsply Sirona | NHA |
| Oct 20, 2021 | K203808 | Multi-unit Abutment, Multi-unit Angled Abutment Megagen Implant Co., Ltd., KR | NHA |
| Oct 9, 2021 | K203750 | Straumann CARES P-Series CAD/CAM System Institut Straumann AG, CH | NHA |
| Sep 24, 2021 | K212108 | Dynamic TiBase Talladium España, SL, ES | NHA |
| Sep 15, 2021 | K203649 | TruAbutment DS, TruBase Truabutment, Inc. | NHA |
| Sep 10, 2021 | K210410 | s-Clean Pre-Milled Abutment Mini Dentis Co., Ltd., KR | NHA |
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