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 |
|---|---|---|---|
| Jan 31, 2008 | K072363 | NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX Biomet 3i, Inc. | DZE |
| Jan 24, 2008 | K071240 | IMPLASA-HOECHST GMBH IMPLANTS Implasa-Hoechst GmbH, IL | DZE |
| Jan 14, 2008 | K072917 | JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM Odontit S.A., AR | DZE |
| Jan 11, 2008 | K073142 | NOBELREPLACE HEXAGONAL IMPLANT Nobel Biocare USA, LLC | DZE |
| Jan 10, 2008 | K072871 | MS SYSTEM (PROVISIONAL) Osstem Implant Co., Ltd. | DZE |
| Dec 28, 2007 | K070857 | NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM Nobel Biocare AB | DZE |
| Dec 20, 2007 | K072980 | NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS Nobel Biocare AB | DZE |
| Dec 13, 2007 | K073049 | SCREWPLUS DENTAL IMPLANTS (HA) Implant Direct, LLC | DZE |
| Dec 12, 2007 | K072660 | ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 Imtec Corp. | DZE |
| Dec 10, 2007 | K073033 | LEGACY DENTAL IMPLANTS Implant Direct, LLC | DZE |
| Dec 6, 2007 | K072649 | SPI SYSTEM DENTAL IMPLANTS Thommen Medical AG | DZE |
| Nov 28, 2007 | K062931 | IMPLUS IMPLANT SYSTEM Leader Italia S.R.L. | DZE |
| Nov 16, 2007 | K071161 | ENDOSSEOUS DENTAL IMPLANT SYSTEM Southern Implants, Inc. | DZE |
| Nov 15, 2007 | K072933 | SPI CONTACT PLATFORM O 4.0 MM Thommen Medical AG | DZE |
| Nov 9, 2007 | K070935 | T.B.R. ZIRCONNECT Sudimplant SA, FR | DZE |
| Nov 8, 2007 | K070569 | SM INTERNAL./EXTERNAL IMPLANT SYSTEM Dio Department Dsi, Inc. | DZE |
| Nov 6, 2007 | K072896 | GS FIXTURE SYSTEM Osstem Implant Co., Ltd. | DZE |
| Oct 29, 2007 | K062542 | Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX Z-Systems AG | DZE |
| Oct 23, 2007 | K072768 | RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS Lifecore Biomedical, Inc. | DZE |
| Oct 23, 2007 | K071070 | OLYMPUS DENTAL IMPLANT SYSTEM Keystone Dental, Inc. | DZE |
| Oct 18, 2007 | K071851 | HDC STERILE SPIDER SCREW Hdc S.R.L., IT | DZE |
| Oct 12, 2007 | K070601 | MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM Intra-Lock International | DZE |
| Oct 10, 2007 | K071638 | BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM BioHorizons Implant Systems, Inc. | DZE |
| Oct 4, 2007 | K072589 | TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16 Zimmer Dental, Inc. | DZE |
| Sep 21, 2007 | K063861 | GS SYSTEM Osstem Implant Co., Ltd. | DZE |
| Sep 20, 2007 | K071439 | ZIMMER PATIENT-SPECIFIC ABUTMENT, INTERNAL HEX, TITANIUM Zimmer Dental, Inc. | DZE |
| Aug 3, 2007 | K071370 | NOBELACTIVE INTERNAL CONNECTION IMPLANT Nobel Biocare AB | DZE |
| Jun 21, 2007 | K070841 | ENDOSSEOUS DENTAL IMPLANT SYSTEM Southern Implants, Inc. | DZE |
| Jun 1, 2007 | K062636 | OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTS Implant Innovations, Inc. | DZE |
| May 30, 2007 | K071235 | ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13 Zimmer Dental, Inc. | DZE |
| May 25, 2007 | K070568 | DIO PROTEM IMPLANT SYSTEM Dio Department Dsi, Inc. | DZE |
| May 24, 2007 | K070905 | ENDOSSEOUS DENTAL IMPLANT SYSTEM Southern Implants, Inc. | DZE |
| May 23, 2007 | K061323 | MODIFICATION TO RELIADENT DENTAL IMPLANT SYSTEM Bioinfera, Inc. | DZE |
| Apr 30, 2007 | K063341 | 3I OSSEOTITE CERTAIN DENTAL IMPLANTS Implant Innovations, Inc. | DZE |
| Apr 27, 2007 | K063779 | OSSEOSPEED 4.0S-6MM, MODEL 24619 Astra Tech, Inc. | DZE |
| Apr 24, 2007 | K063286 | OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE Implant Innovations, Inc. | DZE |
| Apr 20, 2007 | K070022 | MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF9 Mis Implants Technologies , Ltd. | DZE |
| Apr 19, 2007 | K070483 | LEONE MONOIMPLANT FOR O-RING OVERDENTURE Leone S.P.A., IT | DZE |
| Apr 4, 2007 | K070182 | ZYGOMA IMPLANT (IMMEDIATE FUNCTION) Nobel Biocare AB | DZE |
| Apr 2, 2007 | K063216 | RESCUE INTERNAL IMPLANT SYSTEM Megagen Co., Ltd. | DZE |
| Mar 29, 2007 | K063874 | DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEM Blue Sky Bio, LLC | DZE |
| Mar 14, 2007 | K063364 | ALPHA BIO DENTAL IMPLANT SYSTEM Alpha-Bio Tec , Ltd. | DZE |
| Mar 6, 2007 | K061971 | ZIRCONIA IMPLANT Nobel Biocare AB | DZE |
| Feb 23, 2007 | K061629 | CERTAIN PREVAIL DENTAL IMPLANT Implant Innovations, Inc. | DZE |
| Feb 22, 2007 | K062432 | NANOTITE DENTAL IMPLANTS Implant Innovations, Inc. | DZE |
| Feb 16, 2007 | K063523 | ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10, 11, 13, 16; ZOP37A10, 11, 13, 16; ZOP47S10, 11, 13, 16; ZOP4 Zimmer Dental, Inc. | DZE |
| Jan 10, 2007 | K070007 | SPI ELEMENT PLATFORM O 4.0 MM Thommen Medical AG | DZE |
| Jan 5, 2007 | K063718 | SFB AND CFB IMPLANTS - 5.0 PLATFORM Nobel Biocare AB | DZE |
| Dec 19, 2006 | K062936 | NOBELPERFECT CONICAL CONNECTION Nobel Biocare AB | DZE |
| Dec 8, 2006 | K062367 | MINISCREWS ANCHORING SYSTEM, M.A.S. Micerium S.P.A., IT | DZE |
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