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 |
|---|---|---|---|
| Jul 1, 2013 | K130408 | ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT Sterngold Dental, LLC | NHA |
| Jun 28, 2013 | K130808 | STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS Straumann USA | NHA |
| Jun 28, 2013 | K123627 | ET SMARTFIT ABUTMENT Hiossen, Inc. | NHA |
| Jun 21, 2013 | K130310 | CERTAIN BELLATEK PROVISIONAL ABUTMENTS Biomet 3i | NHA |
| Jun 5, 2013 | K120954 | NOBELPROCERA PEEK ABUTMENTS Nobel Biocare AB | NHA |
| May 30, 2013 | K123491 | BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT Biodenta Swiss AG, CH | NHA |
| May 3, 2013 | K122559 | BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS Biodenta Swiss AG, CH | NHA |
| May 1, 2013 | K130216 | ATLANTIS STRAUMANN BONE LEVEL ABUTMENT Dentsply Implant | NHA |
| Apr 26, 2013 | K123755 | MULTI ANGLED ABUTMENT Osstem Implant Co., Ltd. | NHA |
| Mar 29, 2013 | K124008 | IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE Ivoclar Vivadent, Agin | NHA |
| Mar 13, 2013 | K122602 | NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS Nobel Biocare AB | NHA |
| Jan 30, 2013 | K113816 | GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV GC America, Inc. | NHA |
| Jan 23, 2013 | K121810 | OSSEOSPEED ANGLED ABUTMENT EV Astra Tech AB | NHA |
| Dec 21, 2012 | K120822 | STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, ST Institut Straumann AG, CH | NHA |
| Dec 14, 2012 | K121117 | NDX ABUTMENTS National Dentex Corp | NHA |
| Dec 11, 2012 | K122268 | ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS Dentsply International | NHA |
| Dec 11, 2012 | K121843 | NP-CAST ABUTMENT SYSTEM Osstem Implant Co., Ltd. | NHA |
| Dec 10, 2012 | K121391 | INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS Prismatik Dentalcraft, Inc. | NHA |
| Dec 6, 2012 | K120858 | IMPLANT BAR Prismatik Dentalcraft, Inc. | NHA |
| Nov 8, 2012 | K120873 | ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM Zimmer Dental, Inc. | NHA |
| Nov 2, 2012 | K122192 | NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEM Straumann USA, LLC | NHA |
| Oct 19, 2012 | K121709 | ZFX DENTAL CAD SYSTEM Zimmer Dental, Inc. | NHA |
| Oct 18, 2012 | K120053 | IPS E.MAX PRESS - ABUTMENT SOLUTIONS Ivoclar Vivadent, AG | NHA |
| Oct 12, 2012 | K121688 | MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM Prismatik Dentalcraft, Inc. | NHA |
| Sep 11, 2012 | K120776 | ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION Biomet 3i | NHA |
| Aug 14, 2012 | K121334 | VARIOECO Thommen Medical AG | NHA |
| Aug 8, 2012 | K112787 | KERATOR Kj Meditech Co., Ltd. | NHA |
| Jul 5, 2012 | K120338 | ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA Astra Tech, Inc. | NHA |
| Mar 1, 2012 | K113003 | ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT... Astra Tech, Inc. | NHA |
| Feb 17, 2012 | K111935 | TI-BASE ABUTMENT, 1 CONNECT ABUTMENT Nt-Trading GmbH and CO KG | NHA |
| Feb 17, 2012 | K111421 | SIRONA DENTAL CAD/CAM SYSTEM Sirona Dental Systems GmbH, DE | NHA |
| Feb 3, 2012 | K112099 | CONTOUR HEALER Contour Healer, LLC | NHA |
| Jan 30, 2012 | K112333 | LRT ATTACHMENT Bcf Certification, Inc., CA | NHA |
| Jan 27, 2012 | K113606 | NNC GOLD ABUTMENT FOR BRIDGES Straumann USA | NHA |
| Jan 26, 2012 | K112045 | SIMPLELINE II ABUTMENT SYSTEM Dentium Co., Ltd., KR | NHA |
| Jan 23, 2012 | K113092 | ZIMMER CONTOUR PROVISIONAL COPING Zimmer Dental, Inc. | NHA |
| Jan 13, 2012 | K113410 | NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENT Straumann USA | NHA |
| Jan 13, 2012 | K112730 | ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION Biomet 3i | NHA |
| Dec 28, 2011 | K113283 | NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS Straumann USA | NHA |
| Dec 8, 2011 | K111853 | ANGLED TAPERED ABUTMENT Zimmer Dental, Inc. | NHA |
| Dec 1, 2011 | K112138 | ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT Astra Tech, Inc. | NHA |
| Nov 16, 2011 | K112280 | STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM Straumann USA | NHA |
| Nov 10, 2011 | K111984 | SPI VARIO ANGLED ABUTMENT Thommen Medical AG | NHA |
| Nov 4, 2011 | K103291 | BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE BioHorizons Implant Systems, Inc. | NHA |
| Nov 3, 2011 | K103691 | BIOHORIZONS ABUTMENTS FOR ZIMMER BioHorizons Implant Systems, Inc. | NHA |
| Oct 28, 2011 | K112259 | NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS Nobel Biocare AB | NHA |
| Oct 3, 2011 | K110308 | PROSTHETIC SYSTEM Osstem Implant Co., Ltd. | NHA |
| Sep 12, 2011 | K111390 | SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA.. Cendres & Metaux SA, CH | NHA |
| Sep 1, 2011 | K110565 | ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE Biomet 3i, Inc. | NHA |
| Aug 12, 2011 | K110580 | NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS Straumann USA | NHA |
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