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 11, 2011 | K111852 | ANODIZED HEALING COLLAR Zimmer Dental, Inc. | NHA |
| Aug 8, 2011 | K111199 | INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS Intra-Lock International, Inc. | NHA |
| Jul 29, 2011 | K110778 | BIODENTA CUSTOMIZED ABUTMENT Biodenta Swiss AG, CH | NHA |
| Jun 30, 2011 | K103234 | GC AADVA BO AC ABUTMENTS GC America, Inc. | NHA |
| Jun 23, 2011 | K111581 | 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVE Nobel Biocare AB | NHA |
| Jun 21, 2011 | K101005 | ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT Astra Tech AB | NHA |
| Jun 15, 2011 | K110171 | NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS Nobel Biocare USA, LLC | NHA |
| Jun 10, 2011 | K110640 | ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT Astra Tech, Inc. | NHA |
| Jun 10, 2011 | K110356 | ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT Astra Tech, Inc. | NHA |
| Apr 20, 2011 | K102804 | SPI TITANIUM BASE FOR CAD/CAM Thommen Medical AG | NHA |
| Apr 8, 2011 | K103759 | ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT Astra Tech, Inc. | NHA |
| Apr 7, 2011 | K102467 | UTA AND UHA Uta | NHA |
| Mar 31, 2011 | K103339 | TDS ABUTMENT FOR FRIADENT XIVE Pou YU Biotechnology Co., Ltd., TW | NHA |
| Mar 11, 2011 | K101608 | BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS Biomet 3i, Inc. | NHA |
| Mar 11, 2011 | K101607 | BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTS Biomet 3i, Inc. | NHA |
| Feb 24, 2011 | K103280 | BHDENTAL IMPLANT SYSTEM Bhdental, Ltd., IL | NHA |
| Feb 3, 2011 | K103020 | ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT Atlantis Components, Inc. | NHA |
| Feb 3, 2011 | K101890 | BALL ABUTMENT SYSTEM Megagen Co., Ltd. | NHA |
| Jan 10, 2011 | K103252 | CAMLOG VARIO SR ABUTMENTS Altatec GmbH | NHA |
| Dec 28, 2010 | K100993 | INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS Prismatik Dentalcraft, Inc. | NHA |
| Dec 13, 2010 | K101465 | STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR Institut Straumann AG | NHA |
| Dec 3, 2010 | K102382 | SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT Cendres & Metaux SA, CH | NHA |
| Dec 3, 2010 | K102209 | ENCODE PATIENT SPECIFIC ABUTMENT Biomet 3i, Inc. | NHA |
| Nov 8, 2010 | K101582 | CAM STRUCTSURE BARS Biomet 3i, Inc. | NHA |
| Oct 22, 2010 | K100152 | SIRONA CAD/CAM SYSTEM Sirona Dental Systems GmbH, DE | NHA |
| Oct 5, 2010 | K100356 | TDS PRECISION DENTAL BAR Pou YU Biotechnology Co., Ltd., TW | NHA |
| Sep 9, 2010 | K100985 | BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK BioHorizons Implant Systems, Inc. | NHA |
| Aug 31, 2010 | K101714 | NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS Nobel Biocare AB | NHA |
| Aug 23, 2010 | K101068 | ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS Radiant Express, LLC | NHA |
| Aug 19, 2010 | K101798 | SPI VARIOMULTI ANGLED ABUTMENT Thommen Medical AG | NHA |
| Aug 17, 2010 | K100245 | HS/HG PROSTHETIC SYSTEM Osstem Implant Co., Ltd. | NHA |
| Aug 16, 2010 | K101004 | ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT Astra Tech, Inc. | NHA |
| Jun 24, 2010 | K093643 | MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS Nobel Biocare AB | NHA |
| Jun 22, 2010 | K090081 | TALLADIUM INTERNATIONAL IMPLANTOLOGY ABUTMENTS Talladium Espana, SL, ES | NHA |
| Jun 4, 2010 | K093975 | SIMPLER TOADSTOOL ABUTMENT, MODEL S19000-S19009 Pan Global Implant, CA | NHA |
| Apr 16, 2010 | K093780 | ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT Astra Tech, Inc. | NHA |
| Mar 4, 2010 | K092857 | VERICORE ABUTMENT IN TITANIUM FOR IMPLANT SYSTEMS Whip-Mix Corp. | NHA |
| Feb 26, 2010 | K083876 | SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT Cendres & Metaux SA, CH | NHA |
| Dec 22, 2009 | K093483 | ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + ABUTMENT Astra Tech, Inc. | NHA |
| Dec 22, 2009 | K091701 | STRAUMANN MODIFIED DENTAL ABUTMENT Institut Straumann AG | NHA |
| Dec 18, 2009 | K093113 | ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT Institut Straumann AG, DE | NHA |
| Dec 15, 2009 | K092814 | STRAUMANN DENTAL ABUTMENTS Straumann Manufacturing, Inc. | NHA |
| Nov 30, 2009 | K092341 | LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION Biomet 3i, Inc. | NHA |
| Nov 3, 2009 | K092377 | PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S Zimmer Dental, Inc. | NHA |
| Oct 30, 2009 | K092403 | TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620 Zimmer Dental, Inc. | NHA |
| Oct 16, 2009 | K091848 | NOBEL/PROCERA IMPLANT BRIDGE Nobel Biocare AB | NHA |
| Oct 6, 2009 | K091907 | NOBELPROCERA IMPLANT BRIDGE ZIRCONIA Nobel Biocare AB | NHA |
| Sep 28, 2009 | K091920 | ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL Astra Tech, Inc. | NHA |
| Sep 25, 2009 | K092248 | SPI CUSTOMIZABLE GINGIVA FORMER Thommen Medical AG | NHA |
| Sep 25, 2009 | K091904 | NOBELPROCERA ZI ABUTMENT Nobel Biocare AB | NHA |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.