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 5, 2015 | K151157 | NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variob Straumann USA, LLC | NHA |
| Jul 31, 2015 | K141970 | DIGITEK TITANIUM ABUTMENT Digitek Dental Solutions Limited, CN | NHA |
| Jul 24, 2015 | K150295 | LOCATOR RTx Zest Anchors, Inc. | NHA |
| Jul 13, 2015 | K150367 | Neodent Implant System Jjgc Industria E Comercio DE Materiais Dentarios S, BR | NHA |
| Jul 2, 2015 | K150296 | Biodenta Customized Abutment-Hybrid Biodenta Swiss AG, CH | NHA |
| Jun 25, 2015 | K143505 | Zimmer Patient-Specific Abutment, Internal Hex, Titanium Zimmer Dental, Inc. | NHA |
| Jun 11, 2015 | K150250 | SternSnap Angled Attachment Sterngold Dental, LLC | NHA |
| Jun 4, 2015 | K150012 | CreoDent Solidex Customized Abutment Creodent Prosthetics, Ltd. | NHA |
| May 1, 2015 | K143528 | Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System Zimmer Dental, Inc. | NHA |
| Feb 20, 2015 | K142167 | MEDENTIKA ABUTMENT SYSTEM Medentika GmbH | NHA |
| Feb 17, 2015 | K143337 | CONELOG Titanium base CAD/CAM Altatec GmbH, DE | NHA |
| Jan 21, 2015 | K142572 | Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System Zimmer Dental, Inc. | NHA |
| Jan 9, 2015 | K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Straumann USA, LLC | NHA |
| Jan 6, 2015 | K141923 | INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X Prismatik Dentalcraft, Inc. | NHA |
| Dec 24, 2014 | K142407 | Straight Stud Attachment Sterngold Dental, LLC | NHA |
| Nov 25, 2014 | K142118 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE Prismatik Dentalcraft, Inc. | NHA |
| Nov 13, 2014 | K142115 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT Prismatik Dentalcraft, Inc. | NHA |
| Nov 12, 2014 | K141457 | DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS Dentium Co., Ltd. | NHA |
| Oct 22, 2014 | K141544 | ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM Zimmer Dental, Inc. | NHA |
| Oct 22, 2014 | K141211 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS Prismatik Dentalcraft, Inc. | NHA |
| Aug 21, 2014 | K140600 | SB ANCHOR Osstem Implant Co., Ltd. | NHA |
| Aug 20, 2014 | K140507 | HIOSSEN PROSTHETIC SYSTEM Osstem Implant Co., Ltd. | NHA |
| Aug 14, 2014 | K140737 | STRAUMANN CARES SCREW RETAINED BARS/BRIDGE Straumann USA, LLC | NHA |
| Aug 7, 2014 | K141871 | Straumann Bone Level NC Angled Screw Retained Abutments Straumann USA, LLC | NHA |
| Jul 29, 2014 | K141120 | ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM Zimmer Dental, Inc. | NHA |
| Jul 24, 2014 | K132749 | NOBELPROCERA OVERDENTURE BAR Nobel Biocare USA, LLC | NHA |
| Jul 18, 2014 | K133551 | ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM Zimmer Dental, Inc. | NHA |
| Jul 7, 2014 | K132214 | ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE Hager& Meisinger GmbH, DE | NHA |
| May 6, 2014 | K131468 | DENRACLE DENTAL ABUTMENT Green Dentech Co, Ltd., TW | NHA |
| Apr 25, 2014 | K134045 | ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEM Zimmer Dental, Inc. | NHA |
| Apr 17, 2014 | K133421 | STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW Straumann USA, LLC | NHA |
| Apr 16, 2014 | K133791 | ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S] Sterngold Dental, LLC | NHA |
| Apr 4, 2014 | K133377 | NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE Nobel Biocare AB | NHA |
| Mar 3, 2014 | K130618 | SFI-ANCHOR Cendres & Metaux SA, CH | NHA |
| Feb 25, 2014 | K133696 | NEODENT IMPLANT SYSTEM Jjgc Industria E Comercio DE Materiais Dentarios S | NHA |
| Feb 25, 2014 | K132814 | SFI-BAR IMPLANT ABUTMENTS Sterngold Dental, LLC | NHA |
| Feb 21, 2014 | K132219 | STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN, Straumann USA, LLC | NHA |
| Jan 30, 2014 | K132746 | NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION Nobel Biocare USA, LLC | NHA |
| Jan 22, 2014 | K131644 | ANKYLOS SYNCONE ABUTMENT 5(DEGREE) Dentsply International, Inc. | NHA |
| Jan 15, 2014 | K132844 | STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES Straumann USA, LLC | NHA |
| Jan 10, 2014 | K130662 | ET PROSTHETIC SYSTEM Osstem Implant Co., Ltd. | NHA |
| Dec 20, 2013 | K132067 | MULTI ANGLED ABUTMENT SYSTEM Hiossen, Inc. | NHA |
| Oct 31, 2013 | K132209 | IPS E.MAX CAD ABUTMENT SOLUTIONS Ivoclar Vivadent, AG | NHA |
| Oct 24, 2013 | K122295 | CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS Core 3D Protech, S.L., ES | NHA |
| Sep 23, 2013 | K131526 | SFI-BAR Cendres & Metaux SA, CH | NHA |
| Sep 17, 2013 | K113738 | CREODENT SOLIDEX CUSTOM ABUTMENT Creodent Prosthetics, Ltd. | NHA |
| Aug 26, 2013 | K131101 | ITERO SOFTWARE Cadent, Ltd. an Align Technology Company | NHA |
| Jul 19, 2013 | K122988 | KLOCKNER DENTAL IMPLANT ABUTMENTS SOADCO, S.L., AD | NHA |
| Jul 7, 2013 | K130183 | SFI BAR ABUTMENTS Sterngold Dental, LLC | NHA |
| Jul 5, 2013 | K122424 | ISUS IMPLANT SUPRASTRUCTURES Dentsply International, Inc. | NHA |
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