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 10, 2020 | K191919 | Elos Accurate Hybrid Base Elos Medtech Pinol A/S, DK | NHA |
| Feb 6, 2020 | K191890 | Elos Accurate Customized Abutment Elos Medtech Pinol A/S, DK | NHA |
| Jan 29, 2020 | K183106 | TruAbutment DS Truabutment, Inc. | NHA |
| Jan 23, 2020 | K192436 | Healing Abutments and Cover Screws Dentium Co., Ltd., KR | NHA |
| Jan 6, 2020 | K191123 | Multi-unit Abutments Medentika GmbH, DE | NHA |
| Jan 3, 2020 | K192893 | Straumann Ceramic Healing Abutments Institut Straumann AG, CH | NHA |
| Jan 2, 2020 | K192457 | Elos Accurate Customized Abutment Elos Medtech Pinol A/S, DK | NHA |
| Dec 19, 2019 | K192229 | Neodent Implant System- GM Titanium Base for Bridge Jjgc Industria E Comercio DE Materiais Dentarios S.A., BR | NHA |
| Dec 9, 2019 | K192522 | TSV BellaTek Express and BellaTek Flex Abutments Biomet 3i, LLC | NHA |
| Dec 5, 2019 | K191250 | Southern Implants PEEK Abutments Southern Implants (Pty), Ltd., ZA | NHA |
| Dec 5, 2019 | K191191 | Neodent Implant System - Temporary Abutments Jjgc Industria E Comercio DE Materiais Dentarios S.A., BR | NHA |
| Nov 10, 2019 | K191986 | DESS Dental Smart Solutions Terrats Medical SL, ES | NHA |
| Nov 4, 2019 | K191634 | Scan Abutments and Comfort Caps Dentium Co., Ltd., KR | NHA |
| Oct 28, 2019 | K192029 | Straumann PUREloc abutments Institut Straumann AG, CH | NHA |
| Oct 10, 2019 | K191458 | Legacy SMARTBase Abutments Implant Direct Sybron Manufacturing, LLC | NHA |
| Sep 30, 2019 | K190048 | UF(II) Anatomic abutment Dio Corporation, KR | NHA |
| Aug 26, 2019 | K191382 | IPS e.max CAD Abutment Solutions- extra systems Ivoclar Vivadent, AG, LI | NHA |
| Aug 12, 2019 | K190491 | Blue Sky Bio Zygomatic Implant System Blue Sky Bio, LLC | NHA |
| Aug 5, 2019 | K191222 | Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV Prismatik Dentalcraft, Inc. | NHA |
| Jul 15, 2019 | K182455 | A.B. DENTAL DEVICES Dental Implants System A.B. Dental Device , Ltd., IL | NHA |
| Jul 12, 2019 | K182091 | Osstem Abutment System Osstem Implant Co., Ltd., KR | NHA |
| Jul 10, 2019 | K183079 | Conometric Abutments Dentsply Sirona, Inc. | NHA |
| Jul 2, 2019 | K183138 | Certain BellaTek Express and BellaTek Flex Abutments Biomet 3i | NHA |
| Jun 28, 2019 | K190654 | Straumann CI RD Ceramic Healing Caps Institut Straumann AG, CH | NHA |
| Jun 26, 2019 | K190299 | Elos Accurate® Customized Abutment Elos Medtech Pinol A/S, DK | NHA |
| Jun 26, 2019 | K190097 | Straumann CARES Screw-Retained Bridges and Bars Institut Straumann AG, CH | NHA |
| Jun 20, 2019 | K183580 | Panthera Dental Milled Bars Panthera Dental, Inc., CA | NHA |
| May 17, 2019 | K173570 | SD Abutment Surgident Co., Ltd., KR | NHA |
| Apr 17, 2019 | K190082 | Straumann BLX Variobase Abutment Institut Straumann AG, CH | NHA |
| Apr 16, 2019 | K182246 | MIST IC Imagine Milling Technologies, LLC | NHA |
| Apr 8, 2019 | K190040 | Straumann BLX Line Extension - New Abutments Institut Straumann AG, CH | NHA |
| Mar 18, 2019 | K183518 | Preat Abutments Preat Corporation | NHA |
| Jan 29, 2019 | K181580 | Cortex CAD/CAM Abutments Cortex Dental Implants Industries , Ltd., IL | NHA |
| Jan 28, 2019 | K182228 | MIS LOCKiT Abutments System, OT-Equators and Ball Attachments Mis Implants Technologies , Ltd., IL | NHA |
| Jan 7, 2019 | K180564 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases Medentika GmbH, DE | NHA |
| Dec 21, 2018 | K181037 | DIO CAD/CAM Abutment Dio Corporation, KR | NHA |
| Dec 12, 2018 | K181869 | On1 Universal Abutment Nobel Biocare AB, SE | NHA |
| Nov 23, 2018 | K181381 | A.B. Dental Devices Dental Implants System A.B. Dental Device , Ltd., IL | NHA |
| Nov 16, 2018 | K180184 | Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System Dentalpoint AG, CH | NHA |
| Oct 31, 2018 | K180899 | Universal Base Abutment Nobel Biocare AB, SE | NHA |
| Oct 11, 2018 | K181520 | Sirona Dental CAD/CAM System Dentsply Sirona | NHA |
| Oct 5, 2018 | K173945 | Straumann SC Variobase Abutments Institut Straumann AG, CH | NHA |
| Sep 28, 2018 | K180998 | BioHorizons CAD/CAM Bars BioHorizons Implant Systems, Inc. | NHA |
| Sep 11, 2018 | K171532 | TruBase S Truabutment, Inc. | NHA |
| Aug 15, 2018 | K181359 | InterActive SMARTBase Abutments Implant Direct Sybron Manufacturing, LLC | NHA |
| Jul 18, 2018 | K181189 | ATLANTIS Conus Structure Dentsply Sirona | NHA |
| Jul 17, 2018 | K173968 | Straumann Variobase for Bridge/Bar Cylindrical Institut Straumann AG, DE | NHA |
| Jun 15, 2018 | K173908 | DESS Dental Smart Solutions Terrats Medical SL, ES | NHA |
| May 23, 2018 | K180609 | Rodo Smilekey Rodo Medical, Inc. | NHA |
| May 18, 2018 | K172430 | ArgenIS Titanium Abutments Argen Corporation | NHA |
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