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 |
|---|---|---|---|
| Dec 5, 2016 | K153015 | Transfer & Angled Abutment Osstem Implant Co., Ltd., KR | NHA |
| Nov 22, 2016 | K161435 | Temporary Snap Abutment Nobel Biocare AB, SE | NHA |
| Nov 21, 2016 | K160786 | RODO Abutment System Rodo Medical, Inc. | NHA |
| Nov 21, 2016 | K160132 | Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC Hager& Meisinger GmbH, DE | NHA |
| Nov 4, 2016 | K160979 | Inclusive Abutments Prismatik Dentalcraft, Inc. | NHA |
| Oct 28, 2016 | K160519 | Link Abutment for CEREC Osstem Implant Co., Ltd., KR | NHA |
| Oct 7, 2016 | K161677 | Straumann Sterile Healing Solution Institut Straumann AG, CH | NHA |
| Sep 29, 2016 | K160436 | CreoDent Solidex Custom Abutment Creodent Prosthetics, Ltd. | NHA |
| Sep 21, 2016 | K160207 | ATLANTIS ISUS Implant Suprastructures Dentsply International, Inc. | NHA |
| Sep 16, 2016 | K160964 | Neodent Implant System - Titanium Base for CEREC Jjgc Industria E Comercio DE Materiais Dentarios S.A., BR | NHA |
| Sep 15, 2016 | K160828 | Dentium Implantium & SuperLine Prosthetics Dentium Co., Ltd., KR | NHA |
| Sep 14, 2016 | K160784 | CAM Titanium Blanks Altatec GmbH, DE | NHA |
| Aug 29, 2016 | K160626 | ATLANTIS Abutment for HIOSSEN ET implant Dentsply Sirona | NHA |
| Aug 26, 2016 | K161030 | ATLANTIS Abutment for CONELOG implant Dentsply Sirona | NHA |
| Aug 26, 2016 | K153509 | GPS Angled Abutment Implant Direct Sybron Manufacturing, LLC | NHA |
| Aug 11, 2016 | K160382 | OT EQUATOR Rhein'83 Srl, IT | NHA |
| Aug 5, 2016 | K160483 | Burn-out Cylinder and Angled Screw Abutments Dentium Co., Ltd., KR | NHA |
| Aug 5, 2016 | K160248 | ArgenIS Titanium Abutments Argen Corporation | NHA |
| Jul 25, 2016 | K160158 | NobelProcera HT ML FCZ Implant Bridge and Framework Nobel Biocare AB, SE | NHA |
| Jun 30, 2016 | K153645 | VITA ENAMIC Implant Solutions (IS) Vita Zahnfabrik H.Rauter GmbH Co., DE | NHA |
| Jun 2, 2016 | K160244 | VARIOunite Thommen Medical AG, CH | NHA |
| Jun 2, 2016 | K153036 | NobelDesign Software Nobel Biocare AB, SE | NHA |
| May 20, 2016 | K152559 | TruAbutment DS Truabutment | NHA |
| Apr 15, 2016 | K153624 | Neodent Implant System Jjgc Industria E Comercio DE Materiais Dentarios S, BR | NHA |
| Apr 13, 2016 | K151608 | 4plus6Line Abutment System Ot Medical GmbH, DE | NHA |
| Mar 31, 2016 | K153779 | Abutment for Bridges Altatec GmbH, DE | NHA |
| Mar 14, 2016 | K152845 | Allied Biocompat Abutment for Nobel Replace Interface Allied Dental Solutions | NHA |
| Mar 10, 2016 | K151984 | Thommen Milling Abutment for CAD/CAM Thommen Medical AG, CH | NHA |
| Mar 4, 2016 | K151789 | LOCATOR F-Tx Attachment System Zest Anchors, LLC | NHA |
| Mar 4, 2016 | K151590 | Straumann RN Gold Abutment for Bridge Straumann USA, LLC | NHA |
| Feb 19, 2016 | K151439 | ATLANTIS ISUS Dentsply International, Inc. | NHA |
| Jan 29, 2016 | K151194 | KLOCKNER DENTAL IMPLANT ABUTMENTS (II) SOADCO, S.L., AD | NHA |
| Jan 14, 2016 | K151039 | ATLANTIS Abutment for NobelActive 3.0 Dentsply International, Inc. | NHA |
| Jan 13, 2016 | K151621 | BioHorizons CAD/CAM Abutments BioHorizons Implant Systems, Inc. | NHA |
| Jan 12, 2016 | K152509 | CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR) Altatec GmbH, DE | NHA |
| Dec 1, 2015 | K151295 | Biodenta Customized Abutment - Titanium Biodenta Swiss AG, CH | NHA |
| Nov 25, 2015 | K142211 | OT EQUATOR Rhein'83 Srl, IT | NHA |
| Nov 16, 2015 | K151798 | Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System Prismatik Dentalcraft, Inc. | NHA |
| Nov 5, 2015 | K151432 | NaturalLine Abutment Ot Medical GmbH, DE | NHA |
| Oct 23, 2015 | K150203 | Medentika CAD/CAM Abutments Medentika GmbH, DE | NHA |
| Oct 8, 2015 | K151169 | OsteoReady ZircoSeal Abutments Osteoready, LLC | NHA |
| Oct 8, 2015 | K150669 | Neoss TiBase, Neoss CoCr Abutments (Mono and Multi) Neoss, Ltd., GB | NHA |
| Oct 7, 2015 | K151375 | Inclusive Titanium Abutments compatible with: Hiossen HG Implant System Prismatik Dentalcraft, Inc. | NHA |
| Oct 1, 2015 | K143515 | Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Impla Prismatik Dentalcraft, Inc. | NHA |
| Sep 21, 2015 | K151564 | Telio CAD Abutment Solutions Ivoclar Vivadent, AG, LI | NHA |
| Sep 16, 2015 | K150899 | Straumann CARES Titanium Alloy (TAN) Abutment Straumann USA, LLC | NHA |
| Sep 16, 2015 | K143051 | ArgenIS Titanium Abutments The Argen Corporation | NHA |
| Sep 11, 2015 | K151324 | Straumann Variobase for CEREC Straumann USA, LLC | NHA |
| Aug 10, 2015 | K151247 | NC Straumann Screw Retained Abutments Straumann USA, LLC | NHA |
| Aug 10, 2015 | K150814 | Straumann Screw-Retained Abutment Straumann USA, LLC | NHA |
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