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 |
|---|---|---|---|
| Jun 4, 2014 | K132585 | ZIBONE CERAMIC DENTAL IMPLANT SYSTEM Coho Technology Co., Ltd. | DZE |
| May 9, 2014 | K131557 | RITTER IMPLANT SYSTEM Ritter Implants GmbH CO KG | DZE |
| May 8, 2014 | K133731 | NOBELACTIVE WIDE PLATFORM (WP) Nobel Biocare AB | DZE |
| Apr 30, 2014 | K132178 | MOSTDI DENTAL IMPLANT SYSTEM Mostdi Innovations Sdn Bhd | DZE |
| Mar 21, 2014 | K132144 | KERATOR LK Consulting Group USA, Inc. | DZE |
| Mar 20, 2014 | K133613 | INTRA-LOCK DENTAL IMPLANTS Intra-Lock International, Inc. | DZE |
| Mar 17, 2014 | K131258 | SATURN DENTAL IMPLANT Cortex Dental Implants Industries , Ltd., IL | DZE |
| Mar 4, 2014 | K133339 | ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED Zimmer Dental, Inc. | DZE |
| Feb 24, 2014 | K133510 | NEODENT IMPLANT SYSTEM Jj Industria E Comercio DE Materiais Dentarios SA | DZE |
| Feb 21, 2014 | K131066 | AXIOM REG Anthogyr Sas, FR | DZE |
| Jan 21, 2014 | K132125 | A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEM A.B. Dental Devices , Ltd. | DZE |
| Jan 8, 2014 | K133049 | 3I T3(R) EXTERNAL HEX DENTAL IMPLANTS Biomet 3i | DZE |
| Dec 24, 2013 | K130572 | INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM Implant Direct Sybron Manufacturing, LLC | DZE |
| Dec 18, 2013 | K132992 | TI STAR IMPLANT SYSTEM T-Plus Implant Tech. Co., Ltd., TW | DZE |
| Dec 12, 2013 | K123861 | AIDI DENTAL IMPLANT SYSTEM Aidi Biomedical, LLC | DZE |
| Dec 11, 2013 | K121873 | AVINENT DENTAL IMPLANT SYSTEM Avinent Implant System S.L., ES | DZE |
| Dec 6, 2013 | K132242 | INNO SLA SUBMERGED IMPLANT SYSTEM Cowellmedi Co., Ltd. | DZE |
| Dec 5, 2013 | K131682 | UD IMPLANT SYSTEM Medimecca Co., Ltd. | DZE |
| Nov 19, 2013 | K132258 | ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM Zimmer Dental, Inc. | DZE |
| Nov 14, 2013 | K131165 | ANKER DENTAL IMPLANT SYSTEM Alliance Global, TW | DZE |
| Nov 14, 2013 | K130829 | IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS Iq Implants , Ltd., IL | DZE |
| Oct 31, 2013 | K131748 | OSSEOFUSE DENTAL IMPLANT SYSTEM Osseofuse, Inc. | DZE |
| Oct 31, 2013 | K123155 | LUNA DENTAL IMPLANT SYSTEM Shinhung Mst Co., Ltd., KR | DZE |
| Oct 25, 2013 | K130999 | OSSEOSPEED PROFILE EV Dentsply Implants Manufacturing GmbH | DZE |
| Sep 5, 2013 | K131701 | Z5MLB, Z5MLC Z-Systems AG | DZE |
| Aug 27, 2013 | K130462 | PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT Paltop Advanced Dental Solutions, Ltd., IL | DZE |
| Aug 22, 2013 | K131451 | PALTOP DENTAL IMPLANT - STERILE ACCESSORIES Paltop Advanced Dental Solutions, Ltd., IL | DZE |
| Aug 22, 2013 | K131097 | LEGACY3 6MM LENGTH IMPLANTS Implant Direct Sybron Manufacturing, LLC | DZE |
| Aug 15, 2013 | K123988 | ANYONETM INTERNAL IMPLANT SYSTEM Megagen Implant Co., Ltd. | DZE |
| Aug 7, 2013 | K131345 | TIARRAY DENTAL IMPLANT SYSTEM Nasseo, Inc. | DZE |
| Aug 1, 2013 | K130140 | INTRA-LOCK OP DENTAL IMPLANT Intra-Lock International | DZE |
| Jul 30, 2013 | K130949 | CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS Biomet 3i | DZE |
| Jul 5, 2013 | K123471 | ETII SA FIXTURE SYSTEM Hiossen, Inc. | DZE |
| Jun 13, 2013 | K130787 | QUANTUM DENTAL IMPLANT SYSTEM Quantum Bioengineering, Ltd. | DZE |
| May 21, 2013 | K122519 | DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM Dio Corporation | DZE |
| May 20, 2013 | K122804 | ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM Intai Technology Corp., TW | DZE |
| May 17, 2013 | K123022 | NEODENT IMPLANT SYSTEM Jjgc Industria E Comercio DE Materiais Dentarios S | DZE |
| May 3, 2013 | K113539 | REVOIS PRO IMPLANT STSYEM Riemser Arzneimittel AG, DE | DZE |
| Apr 30, 2013 | K122664 | ZUGA DENTAL IMPLANT SYSTEM Zuga Medical, Inc. | DZE |
| Apr 29, 2013 | K130222 | STRAUMANN DENTAL IMPLANT SYSTEM Straumann USA, LLC | DZE |
| Apr 26, 2013 | K123386 | PERIOTYPE X-PERT Clinical House Europe GmbH | DZE |
| Apr 10, 2013 | K123784 | STRAUMANN DENTAL IMPLANT SYSTEM Straumann USA, LLC | DZE |
| Apr 5, 2013 | K122198 | 6.00MM X 6.00MM MACRO EXTERNAL IMPLANT SYSTEM Oco Biomedical | DZE |
| Apr 5, 2013 | K121281 | SIMPLI SIMPLER IMPLANT SYSTEM Simpler Implant Solutions, CA | DZE |
| Mar 28, 2013 | K123512 | BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM Biodenta Swiss AG, CH | DZE |
| Mar 27, 2013 | K123870 | XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM Megagen Implant Co., Ltd. | DZE |
| Mar 21, 2013 | K130221 | HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM Medimecca Co., Ltd. | DZE |
| Mar 19, 2013 | K123415 | BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED Biodenta Swiss AG, CH | DZE |
| Mar 13, 2013 | K120089 | BIOGENESIS IMPLANT SYSTEM Biogenesis Co., Ltd. | DZE |
| Mar 8, 2013 | K113042 | REVOIS IMPLANT SYSTEM Riemser Arzneimittel AG | DZE |
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