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 2, 2003 | K031747 | SPI DENTAL IMPLANT ABUTMENTS Thommen Medical AG | NHA |
| Jul 2, 2003 | K031719 | ESTHETIC ZIRCONIA ABUTMENT Nobel Biocare AB | NHA |
| Nov 13, 2002 | K023645 | SPI EASY DENTAL IMPLANT ABUTMENT Thommen Medical AG | NHA |
| Nov 7, 2002 | K023631 | ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS Astra Tech, Inc. | NHA |
| Aug 30, 2002 | K022795 | MODIFICATION TO THE MAESTRO SYSTEM BioHorizons Implant Systems, Inc. | NHA |
| May 22, 2002 | K021460 | OCO DENTAL IMPLANT O Co., Inc. | NHA |
| Mar 20, 2002 | K014175 | SULZER DENTAL CERAMIC SYSTEM-HEXLOCK Sulzer Dental, Inc. | NHA |
| Jan 23, 1998 | K974150 | PROCERA PREPARABLE ABUTMENT SYSTEM Nobel Biocare Uas, Inc. | NHA |
| Sep 12, 1997 | K972475 | AURADAPT AUBTMENT SYSTEM Nobel Biocare Uas, Inc. | NHA |
| Jul 21, 1997 | K971706 | TIADAPT ABUTMENT SYSTEM Nobel Biocare Uas, Inc. | NHA |
| Jul 3, 1997 | K970073 | BIO-ESTHETIC INDIRECT ABUTMENT Steri-Oss, Inc. | NHA |
| Jul 18, 1996 | K961736 | 17 ANGULATED ABUTMENT Nobelpharma USA, Inc. | NHA |
| Jul 10, 1996 | K961728 | MIRUSCONE ABUTMENT SYSTEM Nobelpharma USA, Inc. | NHA |
| Jul 27, 1993 | K925349 | ONE SYSTEM TAPERED TITANIUM ABUTMENTS Implant Support Systems, Inc. | NHA |
| Apr 20, 1993 | K925779 | BRANEMARK SYSTEM TITANIUM HEALING ABUTMENTS Nobelpharma USA, Inc. | NHA |
| Apr 14, 1993 | K925769 | BRANEMARK SYSTEM ABUTMENTS COMPLETE Nobelpharma USA, Inc. | NHA |
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