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 |
|---|---|---|---|
| Sep 22, 2009 | K091756 | NOBELPROCERA TI ABUTMENT Nobel Biocare AB | NHA |
| Jul 30, 2009 | K091693 | TDS ZIRCONIA ABUTMENT FOR NOBEL BIOCARE BRANEMARK Pou YU Biotechnology Co., Ltd., TW | NHA |
| Jul 30, 2009 | K091392 | TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK Pou YU Biotechnology Co., Ltd., TW | NHA |
| Jun 25, 2009 | K090976 | VERICORE ABUTMENT IN ZIRCONIA FOR IMPLANT SYSTEMS Whip-Mix Corp. | NHA |
| Jun 24, 2009 | K091026 | TDS ABUTMENT FOR NOBEL BIOCARE REPLACE Pou YU Biotechnology Co., Ltd., TW | NHA |
| Jun 18, 2009 | K090347 | CAMLOG ABUTMENTS PS Altatec GmbH | NHA |
| Jun 5, 2009 | K090397 | XPI ANGLED ABUTMENTS Keystone Dental, Inc. | NHA |
| May 7, 2009 | K090069 | PROCERA IMPLANT BRIDGE OVERDENTURE Nobel Biocare AB | NHA |
| May 5, 2009 | K083480 | INCLUSIVE ZIRCONIA ABUTMENT BLANKS Inclusive Dental Solutions | NHA |
| Apr 15, 2009 | K083871 | ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE Astra Tech, Inc. | NHA |
| Apr 7, 2009 | K090723 | HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5, Zimmer Dental, Inc. | NHA |
| Mar 27, 2009 | K090153 | SPI VARIOMULTI ANGLED ABUTMENT Thommen Medical AG | NHA |
| Mar 4, 2009 | K083192 | INCLUSIVE TITANIUM ABUTMENT BLANKS Inclusive Dental Solutions | NHA |
| Mar 2, 2009 | K081851 | NEOSS ACCESS ABUTMENTS Neoss, Ltd., GB | NHA |
| Feb 25, 2009 | K083324 | LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM Zest Anchors, Inc. | NHA |
| Feb 2, 2009 | K083544 | KAT IMPLANT SYSTEM Kat Implants, LLC | NHA |
| Jan 14, 2009 | K081396 | SWISSPLANT DENTAL IMPLANT SYSTEM Implant Direct, LLC | NHA |
| Jan 14, 2009 | K081101 | SPECTRA-SYSTEM ABUTMENTS 2008 Implant Direct, LLC | NHA |
| Dec 23, 2008 | K083474 | ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT Zimmer Dental, Inc. | NHA |
| Dec 2, 2008 | K081786 | ZIOCERA & CONVERTIBLE SYSTEM Osstem Implant Co., Ltd. | NHA |
| Nov 21, 2008 | K081460 | TDS ABUTMENT Pou YU Biotechnology Co., Ltd. | NHA |
| Nov 20, 2008 | K082299 | VERICORE IMPLANT ABUTMENTS Whip-Mix Corp. | NHA |
| Nov 19, 2008 | K083100 | GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP Nobel Biocare USA, LLC | NHA |
| Nov 7, 2008 | K083141 | SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM Simpact, LLC | NHA |
| Oct 17, 2008 | K082545 | STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS Institut Straumann AG | NHA |
| Oct 7, 2008 | K081666 | ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED 3.0 IMPLANTS Astra Tech, Inc. | NHA |
| Oct 1, 2008 | K082764 | STRAUMANN WN CARES TITANIUM ABUTMENT Institut Straumann AG | NHA |
| Sep 25, 2008 | K080164 | ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT Zimmer Dental, Inc. | NHA |
| Sep 2, 2008 | K081575 | HU/HS/HG PROSTHETIC SYSTEM Osstem Implant Co., Ltd. | NHA |
| Jul 22, 2008 | K081157 | ACCUFRAME Cagenix, Inc. | NHA |
| Jul 21, 2008 | K080864 | CAM STRUCTSURE PRECISION MILLED BARS Biomet 3i, Inc. | NHA |
| May 23, 2008 | K081186 | CONCAVE RN HEALING CAP Institut Straumann AG | NHA |
| May 21, 2008 | K080598 | MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS Intra-Lock International | NHA |
| May 14, 2008 | K073217 | INCLUSIVE IMPLANT ABUTMENTS Inclusive Dental Solutions | NHA |
| May 6, 2008 | K080397 | AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM American Dental Implant Corporation | NHA |
| May 2, 2008 | K081005 | P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS Institut Straumann AG | NHA |
| Apr 30, 2008 | K080239 | P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS Straumann Manufacturing, Inc. | NHA |
| Mar 27, 2008 | K072730 | FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS Dentsply Intl. | NHA |
| Mar 7, 2008 | K080286 | CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS Straumann USA | NHA |
| Mar 7, 2008 | K073345 | CERTAIN CONTOURED MARGIN CERAMIC ABUTMENT Biomet 3i, Inc. | NHA |
| Mar 5, 2008 | K073553 | CAMLOG IMPLANT SYSTEM ABUTMENTS Altatec GmbH | NHA |
| Feb 29, 2008 | K073540 | ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT Atlantis Components, Inc. | NHA |
| Feb 26, 2008 | K072055 | LAVA FRAME, LAVA FRAME SHADE 3M Espe AG Dental Products, DE | NHA |
| Feb 22, 2008 | K072129 | NOBELACTIVE ZIRCONIA ABUTMENT Nobel Biocare AB | NHA |
| Feb 15, 2008 | K072856 | SPI VARIOMULTI ABUTMENT Thommen Medical AG | NHA |
| Feb 14, 2008 | K073258 | ATLANTIS ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI + ABUTMENT Atlantis Components, Inc. | NHA |
| Feb 14, 2008 | K072100 | GC AADVA ABUTMENT GC America, Inc. | NHA |
| Feb 12, 2008 | K073073 | ANKYLOS TEMPORARY ABUTMENT BALANCE Dentsply International, Inc. | NHA |
| Jan 22, 2008 | K073628 | SYNOCTA ABUTMENTS Straumann USA | NHA |
| Dec 28, 2007 | K072570 | NOBELACTIVE MULTI UNIT ABUTMENT Nobel Biocare AB | NHA |
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