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 20, 2007 | K072642 | BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS Biomet 3i, Inc. | NHA |
| Dec 5, 2007 | K073141 | SPI ART ABUTMENT Thommen Medical AG | NHA |
| Dec 3, 2007 | K072878 | MODIFICATION TO: LOCATOR IMPLANT ANCHOR Zest Anchors, Inc. | NHA |
| Nov 20, 2007 | K070228 | IMPLANTIUM PROSTHETICS Dentium Co., Ltd. | NHA |
| Nov 16, 2007 | K073032 | PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS Lifecore Biomedical, Inc. | NHA |
| Nov 16, 2007 | K072483 | ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI ABUTMENT IN ZIRCONIA FOR ASTRA IMPLANTS Atlantis Components, Inc. | NHA |
| Nov 9, 2007 | K072241 | PRIMACONNEX CAD/CAM ABUTMENT SYSTEM Lifecore Biomedical, Inc. | NHA |
| Oct 19, 2007 | K071838 | NEOSS VARIOUS TITANIUM ABUTMENTS Neoss, Ltd., GB | NHA |
| Oct 15, 2007 | K071888 | STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES Straumann USA | NHA |
| Oct 12, 2007 | K072679 | P.004 ABUTMENTS Institut Straumann AG | NHA |
| Oct 5, 2007 | K072572 | PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS Lifecore Biomedical, Inc. | NHA |
| Oct 5, 2007 | K071946 | ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS Atlantis Components, Inc. | NHA |
| Oct 1, 2007 | K072624 | ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT Astra Tech AB | NHA |
| Sep 26, 2007 | K072497 | P.004 NC GOLD ABUTMENT FOR CROWNS Institut Straumann AG | NHA |
| Sep 26, 2007 | K071919 | P.004 ABUTMENTS Straumann USA (On Behalf of Institut Straumann Ag) | NHA |
| Sep 26, 2007 | K071357 | P.004 NC ANATOMIC ABUTMENTS Institut Straumann AG | NHA |
| Sep 20, 2007 | K070478 | P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP) Straumann Manufacturing, Inc. | NHA |
| Sep 19, 2007 | K071453 | SPI EASY 4.0 ABUTMENT Thommen Medical AG | NHA |
| Sep 11, 2007 | K072151 | P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS Straumann USA | NHA |
| Aug 31, 2007 | K070549 | STRAUMANN P.004 RC GOLD ABUTMENT Institut Straumann AG | NHA |
| Aug 30, 2007 | K071551 | QUICKBRIDGE TM CYLINDER AND CAP Biomet 3i, Inc. | NHA |
| Aug 15, 2007 | K072071 | STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS Institut Straumann AG | NHA |
| Aug 10, 2007 | K071213 | CAMLOG LOGFIT PROSTHETIC SYSTEM Altatec GmbH | NHA |
| Jul 11, 2007 | K071585 | P.004 HEALING ABUTMENTS AND CLOSURE SCREWS Straumann USA | NHA |
| Jun 29, 2007 | K070744 | NARROW NECK TEMPORARY COPING Institut Straumann AG | NHA |
| Jun 27, 2007 | K063768 | TITANIUM SCALLOPED ABUTMENT Vident | NHA |
| Jun 22, 2007 | K070833 | ATLANTIS ABUTMENT FOR ASTRA IMPLANT Atlantis Components, Inc. | NHA |
| Jun 21, 2007 | K070533 | BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS B.T.I. Biotechnology Institute, Sl., ES | NHA |
| Jun 11, 2007 | K063106 | REVOIS IMPLANT SYSTEM Curasan AG | NHA |
| May 18, 2007 | K070562 | EZ PLUS IMPLANT SYSTEM Megagen Co., Ltd. | NHA |
| May 10, 2007 | K063789 | WN SYNOCTA GOLD ABUTMENT Straumann USA | NHA |
| Apr 12, 2007 | K061277 | STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING Straumann USA | NHA |
| Mar 20, 2007 | K063403 | CONICAL ANGLED ABUTMENT Implant Innovations, Inc. | NHA |
| Mar 2, 2007 | K063734 | ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE Atlantis Components, Inc. | NHA |
| Feb 28, 2007 | K062197 | ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT Atlantis Components, Inc. | NHA |
| Feb 27, 2007 | K063592 | ADAPTER PS RP-NP, 34551, ADAPTER PS WP-RP,34552, ABUTMENT SCREW PS RP-NP, 34553, ABUTMENT SCREW PS WP-RP, 34554 Nobel Biocare AB, SE | NHA |
| Feb 14, 2007 | K062069 | ATLANTIS ABUTMENT FOR 3I MICROMINI IMPLANT Atlantis Components, Inc. | NHA |
| Dec 20, 2006 | K062277 | ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE Atlantis Components, Inc. | NHA |
| Nov 29, 2006 | K062749 | SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM Nobel Biocare AB, SE | NHA |
| Nov 22, 2006 | K061567 | BIOHORIZONS CERAMIC ABUTMENT BioHorizons Implant Systems, Inc. | NHA |
| Nov 17, 2006 | K062493 | LAVA SOFTWARE 3M Espe AG Dental Products, DE | NHA |
| Nov 1, 2006 | K062876 | PRIMACONNEX CERAMIC ABUTMENTS Lifecore Biomedical, Inc. | NHA |
| Oct 12, 2006 | K061847 | ZIMMER CONTOUR CERAMIC ABUTMENT, MODELS ZRA341S, ZRA342S, KRA451S, ZRA452S Zimmer Dental, Inc. | NHA |
| Aug 23, 2006 | K061529 | PROCERA ZIRCONIA ABUTMENT FOR CAMLOG IMPLANT SYSTEM Nobel Biocare AB | NHA |
| Aug 21, 2006 | K061478 | PROCERA TITANIUM ABUTMENT FOR ASTRATECH AND CAMLOG IMPLANT SYSTEMS Nobel Biocare AB | NHA |
| Aug 11, 2006 | K061477 | MULTI-UNIT ABUTMENTS FOR ASTRATECH, CAMLOG AND ANKYLOS IMPLANT SYSTEMS Nobel Biocare AB | NHA |
| Jul 31, 2006 | K061807 | SPI ART ABUTMENTS Thommen Medical AG | NHA |
| Jul 31, 2006 | K053654 | ATLANTIS ABUTMENT FOR NOBEL REPLACE INTERFACE Atlantis Components, Inc. | NHA |
| Jul 27, 2006 | K052957 | IMPLANTIUM PROSTHETICS Dentium Co., Ltd. | NHA |
| Jul 21, 2006 | K061969 | PREFORMANCE POSTS AND TEMPORARY CYLINDERS Implant Innovations, Inc. | NHA |
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