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 |
|---|---|---|---|
| Jun 30, 2006 | K053373 | ATLANTIS ABUTMENT FOR ZIMMER INTERFACE Atlantis Components, Inc. | NHA |
| Jun 27, 2006 | K061043 | ZIMMER CONTOUR RESTORATIVE SYSTEM Zimmer Dental, Inc. | NHA |
| May 19, 2006 | K060063 | LEGACY ABUTMENT SYSTEM Implant Direct, LLC | NHA |
| May 17, 2006 | K060880 | ZIMMER DENTAL ONE PIECE TAPERED ABUTMENT, MODELS TAC1, TACW1, TA5C1 Zimmer Dental, Inc. | NHA |
| May 16, 2006 | K061177 | PROVIDE TEMPORARY CYLINDER Implant Innovations, Inc. | NHA |
| Mar 3, 2006 | K053450 | ATLANTIS ABUTMENT FOR ZIMMER INTERFACE Atlantis Components, Inc. | NHA |
| Feb 27, 2006 | K060291 | PREFORMANCE TEMPORARY CYLINDER Implant Innovations, Inc. | NHA |
| Feb 22, 2006 | K053125 | PROCERA BRIDGE ZIRCONIA Nobel Biocare AB | NHA |
| Feb 22, 2006 | K053068 | PROCERA BRIDGE LAMINATE, MODEL 40-4002 Nobel Biocare AB | NHA |
| Feb 22, 2006 | K053050 | PROCERA BRIDGE ALUMINA Nobel Biocare AB | NHA |
| Feb 21, 2006 | K052823 | IMPLANTIUM ABUTMENTS Dentium, Inc. | NHA |
| Feb 17, 2006 | K051636 | CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES Altatec GmbH | NHA |
| Feb 14, 2006 | K053099 | BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS BioHorizons Implant Systems, Inc. | NHA |
| Feb 10, 2006 | K053602 | PROCERA SOFTWARE, MODEL 33145 Nobel Biocare AB | NHA |
| Feb 1, 2006 | K053170 | PREFORMANCE POSTS Implant Innovations, Inc. | NHA |
| Jan 27, 2006 | K053091 | PROCERA IMPLANT BRIDGE ZIRCONIA Nobel Biocare AB | NHA |
| Jan 23, 2006 | K053643 | STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 Lifecore Biomedical, Inc. | NHA |
| Jan 3, 2006 | K052272 | STRAUMANN COMPUTER AIDED RESTORATION SERVICE Straumann USA | NHA |
| Dec 23, 2005 | K052885 | ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315 Nobel Biocare USA, LLC | NHA |
| Oct 20, 2005 | K052648 | MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS Implant Innovations, Inc. | NHA |
| Oct 19, 2005 | K051501 | ZIRACE Acucera, Inc., KR | NHA |
| Oct 14, 2005 | K052070 | ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT IN ZIRCONIA, ATLANTIS GEMEINI + ABUTMENT IN ZIRCONIA Atlantis Components, Inc. | NHA |
| Oct 13, 2005 | K052600 | ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED) Zimmer Dental, Inc. | NHA |
| Jul 28, 2005 | K051527 | SPI EASY TEMPORARY CAP Thommen Medical AG | NHA |
| Jul 22, 2005 | K051652 | ATLANTIS ABUTMENT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI+ ABUTMENT Atlantis Components, Inc. | NHA |
| Jul 12, 2005 | K051011 | ENDOSSEOUS DENTAL IMPLANT ABUTMENT Atlantis Components, Inc. | NHA |
| Jul 12, 2005 | K043428 | RELIADENT DENTAL IMPLANT SYSTEM Bioinfera, Inc. | NHA |
| Jul 7, 2005 | K051717 | RN SYNOCTA TEMPORARY MESO ABUTMENT Institut Straumann SA | NHA |
| Jul 7, 2005 | K050444 | NOBELREPLACE ADAPTER, MODEL 32412 Nobel Biocare Uas, Inc. | NHA |
| Jun 14, 2005 | K050208 | FRIADENT ESTHETICAP Dentsply International | NHA |
| Apr 7, 2005 | K050641 | ZYGOMA TIUNITE Nobel Biocare USA, LLC | NHA |
| Mar 23, 2005 | K042715 | TITAN DENTAL IMPLANT ATTACHMENT Titan Implants, Inc. | NHA |
| Mar 7, 2005 | K050052 | ATLANTIS ABUTMENT FOR STRAUMANN INTERFACE Atlantis Components, Inc. | NHA |
| Dec 14, 2004 | K043190 | SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM Innova Life Sciences Corp. | NHA |
| Nov 24, 2004 | K042466 | X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE Zest Anchors, Inc. | NHA |
| Nov 18, 2004 | K043042 | PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052 Nobel Biocare AB | NHA |
| Oct 20, 2004 | K042658 | PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 Nobel Biocare Uas, Inc. | NHA |
| Jul 23, 2004 | K041070 | STRAUMANN TEMPORARY COPING The Straumann Co. | NHA |
| May 27, 2004 | K041275 | PROCERA ABUTMENT OCTAGON Nobel Biocare Uas, Inc. | NHA |
| May 26, 2004 | K041236 | PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052 Nobel Biocare AB | NHA |
| May 24, 2004 | K041295 | RN SYNOCTA UCLA GOLD ABUTMENT FOR THE STRAUMANN DENTAL IMPLANT Institut Straumann AG | NHA |
| Apr 28, 2004 | K040573 | NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236 Nobel Biocare Uas, Inc. | NHA |
| Mar 24, 2004 | K034035 | 3I PATIENT-SPECIFIC OVERDENTURE BAR Implant Innovations, Inc. | NHA |
| Mar 22, 2004 | K040205 | INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTS Intra-Lock International | NHA |
| Mar 18, 2004 | K040539 | ELLIPTIC MATRIX Institut Straumann AG | NHA |
| Feb 23, 2004 | K033724 | NOBEL BIOCARE CENTRIC POST, MODELS 31234, 31235 AND 31236 Nobel Biocare Uas, Inc. | NHA |
| Nov 3, 2003 | K033346 | SPI EASY DENTAL IMPLANT PROTECTIVE CAP Thommen Medical AG | NHA |
| Oct 20, 2003 | K033243 | ITI SYNOCTA MESO ABUTMENTS Straumann USA | NHA |
| Aug 27, 2003 | K032498 | DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM) Straumann USA | NHA |
| Aug 22, 2003 | K032448 | ALTATEC CERAMIC ABUTMENT Altatec Biotechnologies | NHA |
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