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 |
|---|---|---|---|
| Aug 25, 2021 | K203344 | Premilled Titanium Block System Innobiosurg Co., Ltd., KR | NHA |
| Aug 19, 2021 | K210362 | s-Clean Pre-Milled Abutment Dentis Co., Ltd., KR | NHA |
| Aug 6, 2021 | K200193 | Kisses Plus Implant System Achimhai Medical Corporation, KR | NHA |
| Aug 4, 2021 | K203464 | DESS Dental Smart Solutions Terrats Medical SL, ES | NHA |
| Aug 2, 2021 | K203542 | Neodent Implant System - Mini Abutment 60° Jjgc Industria E Comercio DE Materiais Dentarios S.A., BR | NHA |
| Jul 28, 2021 | K211225 | MIS Ti-base abutment Dentsply Sirona | NHA |
| Jul 23, 2021 | K210903 | IS Multi Unit Abutment System Neobiotech Co., Ltd., KR | NHA |
| Jul 8, 2021 | K202579 | TruAbutment DS, TruBase Truabutment, Inc. | NHA |
| Jun 23, 2021 | K203456 | Straumann CARES M-Series CAD/CAM System Institut Straumann AG, CH | NHA |
| Jun 4, 2021 | K201842 | TruBase S Truabutment, Inc. | NHA |
| Apr 27, 2021 | K203240 | AccelX Abutments Integrated Dental Systems, LLC | NHA |
| Apr 2, 2021 | K202909 | CreoDent Solidex Customized Abutment Creodent Prosthetics, Ltd. | NHA |
| Mar 26, 2021 | K201197 | TruAbutment DS, TruBase S Truabutment, Inc. | NHA |
| Mar 18, 2021 | K201681 | Straumann Immediate Temporary Abutments Institut Straumann AG, CH | NHA |
| Mar 16, 2021 | K203252 | Multi-unit Abutments for CONELOG BioHorizons Implant Systems, Inc. | NHA |
| Feb 19, 2021 | K201860 | Elos Accurate Hybrid Base Elos Medtech Pinol A/S, DK | NHA |
| Feb 12, 2021 | K203355 | Straumann TLX Novaloc and Cementable Abutments Institut Straumann AG, CH | NHA |
| Feb 12, 2021 | K192742 | Straumann Variobase C Institut Straumann AG, DE | NHA |
| Jan 29, 2021 | K202282 | Neodent Implant System - Zirconia Implant System Jjgc Industria E Comercio DE Materiais Dentarios S.A., BR | NHA |
| Dec 18, 2020 | K202026 | Blue Sky Bio CAD-CAM Abutments Blue Sky Bio, LLC | NHA |
| Dec 16, 2020 | K202095 | CreoDent Solidex Customized Abutment and Screw Creodent Prosthetics, Ltd. | NHA |
| Dec 8, 2020 | K201711 | CARES Screw - Retained Bars and Bridges (SRBB) Medentika GmbH, DE | NHA |
| Dec 3, 2020 | K202452 | NobelProcera Zirconia Implant Bridge Nobel Biocare AB, SE | NHA |
| Dec 3, 2020 | K202418 | Magic UCLA Abutment System Innobiosurg Co., Ltd., KR | NHA |
| Nov 25, 2020 | K202269 | PRE-MILLED Abutment Mit Global Co., Ltd., KR | NHA |
| Nov 16, 2020 | K193193 | Telio CAD Abutment Solutions- extra systems Ivoclar Vivadent, AG, LI | NHA |
| Oct 27, 2020 | K193084 | TIB Abutment System Southern Implants (Pty), Ltd., ZA | NHA |
| Sep 2, 2020 | K200827 | LOCATOR R-Tx Ivory Super Holdco, Incp. | NHA |
| Aug 19, 2020 | K200597 | Straumann BLX Gold Abutments Straumann USA, LLC (On Behalf of Institut Straumann Ag) | NHA |
| Aug 16, 2020 | K193408 | Sirona Dental CAD/CAM System with CEREC Chairside Software Dentsply Sirona | NHA |
| Aug 13, 2020 | K193046 | Straumann® Retentive System Novaloc TiN Abutments Institut Straumann AG, CH | NHA |
| Jul 22, 2020 | K200355 | Duranext Abutments Elegant Dental Corp. | NHA |
| Jul 15, 2020 | K201621 | Magicore II System Innobiosurg Co., Ltd., KR | NHA |
| Jul 6, 2020 | K191152 | MIS Ti-base Abutment Dentsply Sirona | NHA |
| Jun 19, 2020 | K191913 | TruAbutment DS Truabutment, Inc. | NHA |
| Jun 9, 2020 | K200753 | IBS Implant System II Innobiosurg Co., Ltd., KR | NHA |
| May 18, 2020 | K193404 | UF(II) Bar holder abutment Dio Corporation, KR | NHA |
| May 8, 2020 | K192218 | Custom Legacy and Custom InterActive Titanium Abutments Implant Direct Sybron Manufacturing, LLC | NHA |
| Apr 8, 2020 | K192108 | Panthera Dental Milled Bars Panthera Dental, Inc., CA | NHA |
| Apr 6, 2020 | K192401 | Straumann Screw-Retained Abutments Straumann USA, LLC | NHA |
| Mar 30, 2020 | K200040 | Universal Base Conical Connection (CC) Nobel Biocare AG, CH | NHA |
| Mar 25, 2020 | K193078 | MIS CONNECT Conical Connection System Dentsply Sirona | NHA |
| Mar 24, 2020 | K193335 | Sherlock Open Implants, LLC | NHA |
| Mar 9, 2020 | K193425 | Pre-Milled Blank Arum Dentistry Co., Ltd., KR | NHA |
| Mar 5, 2020 | K193529 | ATLANTIS Abutment for MIS Conical Connection Implants Dentsply Sirona | NHA |
| Mar 3, 2020 | K193064 | Atlantis suprastructures Dentsply Sirona, Inc. | NHA |
| Feb 27, 2020 | K193274 | Rodo Abutment System Rodo Medical, Inc. | NHA |
| Feb 26, 2020 | K200189 | Luna Dental Implant System- Healing Abutment Shinhung Mst Co., Ltd., KR | NHA |
| Feb 21, 2020 | K192263 | UCLA CCM Abutment Dio Corporation, KR | NHA |
| Feb 13, 2020 | K192614 | Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment Megagen Implant Co., Ltd., KR | NHA |
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