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 |
|---|---|---|---|
| Apr 22, 2004 | K033699 | LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586 Zest Anchors, Inc. | DZE |
| Apr 21, 2004 | K033630 | MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK Rhein 83 Srl | DZE |
| Apr 9, 2004 | K040714 | HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT Innova Corp. | DZE |
| Apr 7, 2004 | K040643 | BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES Branemark Integration AB, SE | DZE |
| Mar 8, 2004 | K034067 | ZTI IMPLANTS SYSTEM, DRM IMPLANTS Drm Research Laboratories, Inc. | DZE |
| Mar 5, 2004 | K034014 | SPI CONTACT DENTAL IMPLANT Thommen Medical AG | DZE |
| Mar 4, 2004 | K032454 | SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM) Bio-Lok Intl., Inc. | DZE |
| Feb 24, 2004 | K033767 | DUAL TOP ANCHOR SYSTEM SCREWS Jeil Medical Corporation | DZE |
| Feb 6, 2004 | K030685 | TEETH IN AN HOUR - ARK IMPLANT CONCEPT Nobel Biocare AB | DZE |
| Jan 30, 2004 | K034022 | UCLA AND CEMENT-ON ABUTMENTS AND ACCESSORIES Diamodent | DZE |
| Jan 28, 2004 | K032263 | 3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR Implant Innovations, Inc. | DZE |
| Jan 15, 2004 | K033483 | KLS-MARTIN ORTHO ANCHORAGE SYSTEM KLS-Martin L.P. | DZE |
| Jan 7, 2004 | K033922 | MODIFICATION TO ITI DENTAL IMPLANT SYSTEM Institut Straumann AG | DZE |
| Jan 7, 2004 | K031936 | OSTEOMED ORTHODONTIC SCREW SYSTEM Osteomed LP | DZE |
| Dec 23, 2003 | K031322 | INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS Intra-Lock International | DZE |
| Dec 10, 2003 | K033392 | IMMEDIATE STABILIZING IMPLANT (ISI) O Co., Inc. | DZE |
| Nov 26, 2003 | K032774 | RENOVA INTERNAL HEX IMPLANT SYSTEM Lifecore Biomedical, Inc. | DZE |
| Nov 7, 2003 | K033430 | 3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615 Implant Innovations, Inc. | DZE |
| Oct 21, 2003 | K032351 | THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT BioHorizons Implant Systems, Inc. | DZE |
| Oct 2, 2003 | K032750 | MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE Friandent GmbH | DZE |
| Oct 2, 2003 | K032302 | XIVE TG ABUTMENTS Friadent GmbH | DZE |
| Oct 2, 2003 | K032140 | 5.0 X 5MM ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM Innova Life Sciences Corp. | DZE |
| Sep 17, 2003 | K032495 | THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEM Lifecore Biomedical, Inc. | DZE |
| Sep 16, 2003 | K031632 | OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS Implant Innovations, Inc. | DZE |
| Sep 15, 2003 | K030614 | 3I DENTAL IMPLANTS Implant Innovations, Inc. | DZE |
| Sep 11, 2003 | K022258 | B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM B.T.I. Biotechnology Institute, Sl., ES | DZE |
| Aug 22, 2003 | K012681 | ANKYLOS Dentsply Ceramco | DZE |
| Aug 14, 2003 | K032284 | XIVE TG DENTAL IMPLANT SYSTEM Friadent GmbH | DZE |
| Aug 14, 2003 | K032158 | XIVE DENTAL IMPLANT SYSTEM MULTIPLE Friadent GmbH | DZE |
| Aug 14, 2003 | K031674 | MODIFICATION TO FRIALIT-2 DENTAL IMPLANT SYSTEM Friadent GmbH | DZE |
| Aug 12, 2003 | K031106 | IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX Imtec Corp. | DZE |
| Aug 12, 2003 | K030639 | XIVE 3.0 DENTAL IMPLANT SYSTEM Friandent GmbH | DZE |
| Jul 28, 2003 | K031475 | OSSEOTITE NT CERTAIN IMPLANTS Implant Innovations, Inc. | DZE |
| Jul 24, 2003 | K031345 | NOBEL DIRECT, MODELS 30937, 30938 Nobel Biocare Uas, Inc. | DZE |
| Jul 7, 2003 | K031055 | ITI DENTAL IMPLANT SYSTEM Straumann USA | DZE |
| Jun 10, 2003 | K024111 | ASTRA TECH IMPLANTS-DENTAL SYSTEM FIXTURE OSSEOSPEED Astra Tech, Inc. | DZE |
| Apr 23, 2003 | K030243 | ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 Imtec Corp. | DZE |
| Mar 31, 2003 | K030007 | ITI DENTAL IMPLANT SYSTEM Straumann USA | DZE |
| Mar 26, 2003 | K030689 | SPI ELEMENT DENTAL IMPLANT O 3.5 MM Thommen Medical AG | DZE |
| Mar 3, 2003 | K024004 | XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM Friadent GmbH | DZE |
| Feb 26, 2003 | K030463 | MODIFICATION TO THE MAESTRO SYSTEM BioHorizons Implant Systems, Inc. | DZE |
| Feb 21, 2003 | K024044 | SABER TECH IMPLANTS SYSTEM Imtec Corp. | DZE |
| Feb 10, 2003 | K030257 | NOBEL PERFECT IMPLANT SYSTEM Nobel Biocare Uas, Inc. | DZE |
| Jan 29, 2003 | K023705 | BICON TRANSITIONAL IMPLANT (BTI) SYSTEM Bicon, Inc. | DZE |
| Jan 17, 2003 | K023580 | STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM Sterngold | DZE |
| Jan 16, 2003 | K023952 | REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE Nobel Biocare Uas, Inc. | DZE |
| Dec 30, 2002 | K022009 | 3I IMPLANTS; OSSEOTITE DENTAL IMPLANTS; OSSEOTITE NT DENTAL IMPLANTS Implant Innovations, Inc. | DZE |
| Dec 30, 2002 | K010185 | 6.0 X 5.7MM DENTAL IMPLANT Bicon, Inc. | DZE |
| Dec 19, 2002 | K021915 | TRANSITIONAL IMPLANTS Intra-Lock International | DZE |
| Dec 3, 2002 | K023067 | IMTEC SENDAX MDI ORTHO6 AND ORTHO8 Imtec Corp. | DZE |
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