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 |
|---|---|---|---|
| May 14, 2018 | K172640 | Dentium Implantium & SuperLine Prosthetics Dentium Co., Ltd., KR | NHA |
| May 4, 2018 | K162021 | 3.0 Dynamic TiBase Talladium Espana, SL, ES | NHA |
| Apr 20, 2018 | K173902 | Neodent Implant System GM Line Jjgc Industria E Comercio DE Materiais Dentarios S.A., BR | NHA |
| Apr 9, 2018 | K171409 | OT EQUATOR Rhein'83 Srl, IT | NHA |
| Mar 30, 2018 | K173379 | Straumann Variobase for Crown AS Institut Straumann AG, DE | NHA |
| Mar 16, 2018 | K173326 | MIS CONNECT Conical Connection Abutment Mis Implants Technologies , Ltd., IL | NHA |
| Mar 16, 2018 | K173120 | CCM Abutment System Innobiosurg Co., Ltd., KR | NHA |
| Feb 22, 2018 | K171649 | Straumann CARES M-Series CAD/CAM System Institut Straumann AG, CH | NHA |
| Feb 9, 2018 | K172160 | Southern Implants PEEK Abutments Southern Implants (Pty), Ltd., ZA | NHA |
| Feb 1, 2018 | K161989 | PREMIUM Implant Systems SHELTA Implant Systems Sweden & Martina S.P.A., IT | NHA |
| Jan 26, 2018 | K173466 | Panthera Dental Milled Bars Panthera Dental, Inc., CA | NHA |
| Jan 23, 2018 | K172304 | TruAbutment DS Truabutment, Inc. | NHA |
| Jan 15, 2018 | K171799 | Elos Accurate Customized Abutment, Elos Prosthetic Screw Elos Medtech Pinol A/S, DK | NHA |
| Jan 11, 2018 | K171622 | Dentium Ti-Base Dentium Co., Ltd., KR | NHA |
| Jan 11, 2018 | K170421 | ET Hybrid Abutment Hiossen, Inc. | NHA |
| Jan 3, 2018 | K172798 | Straumann CARES Abutments CoCr Institut Straumann AG, CH | NHA |
| Dec 14, 2017 | K172854 | NobelPerfect Abutments Nobel Biocare AB, SE | NHA |
| Dec 13, 2017 | K173374 | TSV BellaTek Encode Healing Abutments Biomet 3i | NHA |
| Dec 1, 2017 | K171773 | Straumann n!ce Glass Ceramic A14 Blocks Institut Straumann AG, CH | NHA |
| Nov 30, 2017 | K172225 | Atlantis Abutment for MIS Implant Dentsply Sirona | NHA |
| Nov 29, 2017 | K171694 | s-Clean TiN Coating Abutments Dentis Co., Ltd., KR | NHA |
| Nov 29, 2017 | K171466 | NobelDesign, DTX Studio Design Nobel Biocare AB, SE | NHA |
| Nov 27, 2017 | K171757 | Straumann Screw Retained Abutments Straumann USA, LLC (On Behalf of Institut Straumann Ag) | NHA |
| Nov 16, 2017 | K170022 | Klockner Vega TiBase for CEREC SOADCO, S.L., AD | NHA |
| Nov 2, 2017 | K170080 | Neodent Implant System - CM Pro PEEK Abutment Jjgc Industria E Comercio DE Materiais Dentarios S.A., BR | NHA |
| Oct 26, 2017 | K171142 | Healing Cap Multi-Unit Titanium Nobel Biocare AB, SE | NHA |
| Sep 28, 2017 | K171922 | Anatotemp Anatomic Dental Implant Healing Abutment Buckeye Medical Technologies, LLC | NHA |
| Sep 22, 2017 | K162848 | Straumann CARES Golden Ti/TiN Abutments Institut Straumann AG, CH | NHA |
| Sep 21, 2017 | K170013 | Eztetic BellaTek Encode Healing Abutments Biomet 3i | NHA |
| Sep 15, 2017 | K170838 | Medentika CAD/CAM TiBases Medentika GmbH, DE | NHA |
| Aug 17, 2017 | K170384 | Dentium NR Line CAD/CAM Abutments Dentium Co., Ltd., KR | NHA |
| Aug 14, 2017 | K163398 | ATLANTIS suprastructures Dentsply Sirona | NHA |
| Aug 8, 2017 | K170588 | DESS Dental Smart Solutions Terrats Medical SL, ES | NHA |
| Jul 24, 2017 | K162633 | Custom Bars Implant Direct Sybron Manufacturing, LLC | NHA |
| Jul 18, 2017 | K170100 | CreoDent Solidex Customized Abutment and Screw Creodent Prosthetics, Ltd. | NHA |
| Jun 7, 2017 | K170356 | Straumann Variobase Abutments Institut Straumann AG, CH | NHA |
| Jun 7, 2017 | K170354 | Straumann Variobase Abutments Institut Straumann AG, CH | NHA |
| Jun 6, 2017 | K170044 | Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System Prismatik Dentalcraft, Inc. | NHA |
| May 25, 2017 | K170259 | TruAbutment DS Truabutment | NHA |
| May 22, 2017 | K161689 | OSSTEM Implant System - Abutment Osstem Implant Co., Ltd., KR | NHA |
| May 8, 2017 | K162734 | CreoDent Solidex Customized Abutment Creodent Prosthetics, Ltd. | NHA |
| Apr 25, 2017 | K160670 | ET US SS Prosthetic system Osstem Implant Co., Ltd., KR | NHA |
| Mar 31, 2017 | K163350 | Multibase Abutments EV and ATLANTIS Suprastructures Dentsply Sirona | NHA |
| Mar 24, 2017 | K162028 | PREMIUM - SHELTA Prosthetic Components Sweden & Martina S.P.A., IT | NHA |
| Mar 16, 2017 | K161416 | Multi-unit Abutment Plus Nobel Biocare AB, SE | NHA |
| Feb 28, 2017 | K161655 | On1 Concept Nobel Biocare AB, SE | NHA |
| Jan 30, 2017 | K162390 | ET Hybrid Abutment Hiossen, Inc. | NHA |
| Dec 16, 2016 | K161713 | Dentium CAD/CAM Abutments Dentium Co., Ltd., KR | NHA |
| Dec 15, 2016 | K160798 | IPS e.max® Press Abutment Solutions for Viteo Base Ti Ivoclar Vivadent, AG, LI | NHA |
| Dec 5, 2016 | K162004 | PREMIUM Implant Systems SHELTA Implant Systems Sweden & Martina S.P.A., IT | NHA |
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