Implant, Endosseous, Root-Form
Regulation 872.3640
19510(k)s in 12 months (1,550 all time)
2recalls in 12 months (212 all time)
192recalls that name a 510(k)
Top companies in DZE
| Company | 510(k)s | Recalls |
|---|---|---|
| Nobel Biocare AB | 33 | 37 |
| Biomet 3i | 11 | 52 |
| Nobelpharma AB | 52 | 0 |
| Zimmer Dental, Inc. | 19 | 30 |
| Straumann USA | 35 | 9 |
| Implant Innovations, Inc. | 37 | 4 |
| Steri-Oss, Inc. | 40 | 0 |
| BioHorizons Implant Systems, Inc. | 26 | 12 |
| Minimatic Implant Technology | 34 | 0 |
| Implant Center of the Palm Beaches | 32 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 6, 2006 | K062566 | NOBELREPLACE TAPERED CONICAL CONNECTION Nobel Biocare USA, LLC | DZE |
| Nov 21, 2006 | K062044 | THE 5.0 X 6.0MM DENTAL IMPLANT Bicon, Inc. | DZE |
| Nov 2, 2006 | K062030 | US SYSTEM Osstem Implant Co., Ltd. | DZE |
| Nov 1, 2006 | K062051 | SS SYSTEM Osstem Implant Co., Ltd. | DZE |
| Oct 20, 2006 | K062156 | SUPER ORTHODONTIC SCREW Osstem Implant Co., Ltd. | DZE |
| Oct 20, 2006 | K062129 | P.0004 IMPLANTS Institut Straumann AG | DZE |
| Sep 29, 2006 | K061319 | SPECTRA SYSTEM Implant Direct, LLC | DZE |
| Sep 8, 2006 | K061717 | ZIMMER ONE-PIECE IMPLANT, 3.7 MM, ANGLED Zimmer Dental, Inc. | DZE |
| Sep 8, 2006 | K061410 | SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT Zimmer Dental, Inc. | DZE |
| Sep 8, 2006 | K052968 | MODIFICATION TO: ORLUS MINI SCREW Ortholution Co., Ltd. | DZE |
| Sep 5, 2006 | K062281 | ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16 Zimmer Dental, Inc. | DZE |
| Sep 1, 2006 | K061797 | SM IMPLANT SYSTEMS Dio Department Dsi, Inc. | DZE |
| Aug 24, 2006 | K060958 | STRAUMANN NARROW NECK IMPLANTS Straumann USA | DZE |
| Aug 11, 2006 | K061176 | STRAUMANN DENTAL IMPLANTS Institut Straumann AG | DZE |
| Aug 9, 2006 | K061335 | ENHANCE DENTAL IMPLANT SYSTEM Coastal Biocare | DZE |
| Aug 8, 2006 | K061500 | SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS Sic Invent AG, DE | DZE |
| Jun 30, 2006 | K061003 | SFB & CFB IMPLANTS Nobel Biocare AB | DZE |
| Jun 20, 2006 | K061169 | ENDOSSEOUS DENTAL IMPLANT Northern Implants, LLC | DZE |
| Jun 16, 2006 | K060501 | IMPLANTIUM II Dentium Co., Ltd. | DZE |
| Jun 16, 2006 | K060500 | SPEEDY ORTHODONTIC SCREW Dentium Co., Ltd. | DZE |
| Jun 1, 2006 | K052254 | MYTIS ARROW XXXX Brainbase Corporation | DZE |
| May 31, 2006 | K053629 | ANCHOR PLUS/NEO ANCHOR PLUS Kj Meditech | DZE |
| May 16, 2006 | K060126 | ABSOANCHOR MICROIMPLANT Dentos, Inc. | DZE |
| May 5, 2006 | K060957 | MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM Blue Sky Bio, LLC | DZE |
| Apr 25, 2006 | K060376 | SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-24 Simpler Implant, Inc., CA | DZE |
| Apr 19, 2006 | K053353 | RESCUE IMPLANT SYSTEM Megagen Co., Ltd. | DZE |
| Apr 13, 2006 | K053354 | INTERMEZZO PLUS FIXTURE Megagen Co., Ltd. | DZE |
| Apr 7, 2006 | K051798 | OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEM Osteomed LP | DZE |
| Apr 5, 2006 | K053478 | ENDOSSEOUS DENTAL IMPLANT SYSTEM Northern Implants, LLC | DZE |
| Mar 24, 2006 | K053384 | FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM Astra Tech, Inc. | DZE |
| Mar 21, 2006 | K051719 | A.B. DENTAL DEVICES A.B. Dental Devices , Ltd., IL | DZE |
| Mar 14, 2006 | K053355 | BTI INTERNA DENTAL IMPLANT SYSTEM B.T.I. Biotechnology Institute, Sl., ES | DZE |
| Feb 27, 2006 | K053088 | SLACTIVE IMPLANTS Institut Straumann AG | DZE |
| Feb 27, 2006 | K050586 | LEONE IMPLANT SYSTEM Leone S.P.A. | DZE |
| Feb 16, 2006 | K050956 | TBR IDEA CONIC/CONIC Sudimplant SA, FR | DZE |
| Jan 30, 2006 | K052654 | KLOCKNER DENTAL IMPLANT, MODEL S3M SOADCO, S.L., AD | DZE |
| Jan 27, 2006 | K052951 | ENDOPORE ANATOMIC ENDOSSEOUS DENTAL IMPLANT SYSTEM Innova Life Sciences Corp. | DZE |
| Jan 23, 2006 | K052997 | ZIMMER DENTAL ONE-PIECE IMPLANT Zimmer Dental, Inc. | DZE |
| Jan 10, 2006 | K052369 | EXFEEL IMPLANT SYSTEM Megagen Co., Ltd. | DZE |
| Jan 6, 2006 | K053242 | PITT-EASY DENTAL IMPLANT SYSTEM Innova Life Sciences Corp. | DZE |
| Dec 23, 2005 | K052471 | HDC SPIDER SCREW Hdc S.R.L. | DZE |
| Dec 22, 2005 | K052733 | ALMITECH INC. DENTAL IMPLANT SYSTEM Almitech, Inc. | DZE |
| Dec 8, 2005 | K052490 | ENDOSSEOUS DENTAL IMPLANT SYSTEM Northern Implants, LLC | DZE |
| Dec 2, 2005 | K053152 | BIOHORIZONS SINGLE-STAGE IMPLANT BioHorizons Implant Systems, Inc. | DZE |
| Oct 21, 2005 | K052061 | MODUS IMF SCREWS 2.0 Medartis, Inc. | DZE |
| Oct 14, 2005 | K050970 | MILO DENTAL IMPLANT SYSTEM Intra-Lock International | DZE |
| Sep 23, 2005 | K051859 | SISTEMA DE IMPLANTE NACIONAL (S.I.N.); DENTAL IMPLANT SYSTEM Sin Sistema DE Implante Nacional Ltda | DZE |
| Sep 20, 2005 | K052419 | MAXIMUS 3.0 AND OS IMPLANTS BioHorizons Implant Systems, Inc. | DZE |
| Sep 19, 2005 | K051552 | O.A.S.I. SYSTEM Lancer Orthodontics, Inc. | DZE |
| Sep 15, 2005 | K051461 | 3I OSSEOTITE DENTAL IMPLANTS Implant Innovations, Inc. | DZE |
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