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 |
|---|---|---|---|
| Sep 26, 2011 | K111287 | ASTRA TECH IMPLANT SYSTEM Astra Tech AB | DZE |
| Sep 15, 2011 | K111003 | BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL Biodenta Swiss AG, CH | DZE |
| Sep 15, 2011 | K103089 | SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS Mis - Implant Technologies , Ltd., IL | DZE |
| Sep 14, 2011 | K103810 | KJ SUBMERGED SYSTEM Kj Meditech Co., Ltd. | DZE |
| Aug 18, 2011 | K103790 | ACE TRIMARK TRICAM DENTAL IMPLANT Ace Surgical Supply Company, Inc. | DZE |
| Jul 29, 2011 | K110548 | OSI O-BALL ABUTMENT HEAD IMPLANTS Juell Dental | DZE |
| Jul 14, 2011 | K110577 | OSSEOFUSE DENTAL IMPLANT SYSTEM Dynamic Innovations, Inc. | DZE |
| Apr 21, 2011 | K103194 | INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM Intra-Lock International, Inc. | DZE |
| Apr 19, 2011 | K102034 | BLUE SKY BIO DENTAL IMPLANT SYSTEM Blue Sky Bio, LLC | DZE |
| Apr 13, 2011 | K101201 | STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064, Kat Implants, LLC | DZE |
| Apr 1, 2011 | K100724 | OSSEOTITE II MODEL XIFOSSXXX Biomet 3i, Inc. | DZE |
| Mar 22, 2011 | K102635 | APOLONIA LASER IMPLANT SYSTEM Csm Implant Co., Ltd. | DZE |
| Mar 11, 2011 | K101913 | ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM Anthogyr Sas, FR | DZE |
| Mar 10, 2011 | K103537 | ET III SA ULTRA WIDE SYSTEM Hiossen, Inc. | DZE |
| Feb 23, 2011 | K101732 | ASTRA TECH IMPLANT SYSTEM Astra Tech AB | DZE |
| Jan 26, 2011 | K101945 | NEODENT IMPLANT SYSTEM Jjgc Industria E Comercio DE Materiais Dentarios S | DZE |
| Jan 25, 2011 | K101225 | PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1 Promimic AB, SE | DZE |
| Jan 10, 2011 | K102822 | IMPLANT-ONE SYSTEM Custom Dental Implants, Inc. | DZE |
| Jan 4, 2011 | K093595 | CERAROOT IMPLANT SYSTEM Oral Iceberg S.L. | DZE |
| Dec 27, 2010 | K100932 | INCLUSIVE MINI IMPLANT Prismatik Dentalcraft, Inc. | DZE |
| Dec 20, 2010 | K102981 | ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM Ace Surgical Supply Company, Inc. | DZE |
| Dec 20, 2010 | K100850 | COWELL IMPLANT SYSTEM Cowellmedi Co., Ltd. | DZE |
| Dec 9, 2010 | K102436 | NOBEL ACTIVE 3.0 Nobel Biocare AB, SE | DZE |
| Dec 6, 2010 | K093749 | GC AADVA IMPLANT SYSTEM GC America, Inc. | DZE |
| Nov 22, 2010 | K102308 | SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS Dentium Co., Ltd. | DZE |
| Nov 22, 2010 | K101755 | AIDI DENTAL IMPLANT SYSTEM Aidi Biomedical, LLC | DZE |
| Nov 10, 2010 | K100100 | DIO STEADY EXTERNAL IMPLANT SYSTEM Dio Corporation | DZE |
| Oct 28, 2010 | K101545 | GENESIS IMPLANT SYSTEM Keystone Dental | DZE |
| Oct 14, 2010 | K093562 | ENDOSSEOUS DENTAL IMPLANT Southern Implants, Inc. | DZE |
| Oct 8, 2010 | K101096 | HT III SA FIXTURE SYSTEM Hiossen, Inc. | DZE |
| Oct 1, 2010 | K101880 | TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT Zimmer Dental, Inc. | DZE |
| Oct 1, 2010 | K101849 | BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT Bicon, LLC | DZE |
| Sep 14, 2010 | K101977 | TAPERED SCREW-VENT T IMPLANT Zimmer Dental, Inc. | DZE |
| Aug 26, 2010 | K082800 | STAR/VENT INTERNAL HEX SCREW IMPLANT Park Dental Research Corp. | DZE |
| Aug 2, 2010 | K101207 | NEODENT IMPLANT SYSTEM Jjgc Industria E Comercio DE Materiais Dentarios S | DZE |
| Jul 28, 2010 | K100411 | VARIOUS DENTAL IMPLANTS Grundy Advanced Biomedical Systems, LLC | DZE |
| Jul 23, 2010 | K092261 | DEFCON TSA/TSH DENTAL IMPLANT SYSTEM Impladent, S.L., ES | DZE |
| Jul 21, 2010 | K082573 | SARGON NON-EXPANDABLE DENTAL IMPLANT Sargon Ent., Inc. | DZE |
| Jul 9, 2010 | K100511 | COTEC DENTAL IMPLANT SYSTEM Cotec Implant Co., Ltd. | DZE |
| Jun 24, 2010 | K100902 | AEDIS(TM) Embed Technology, LLC | DZE |
| Jun 3, 2010 | K093630 | BIODENTA DENTAL IMPLANT SYSTEM Biodenta Swiss AG, CH | DZE |
| May 11, 2010 | K092507 | ZIT-Z Ziterion, DE | DZE |
| Apr 23, 2010 | K092542 | M Mediscitec, Inc. | DZE |
| Apr 22, 2010 | K093889 | MODIFICATION TO: HG III ULTRA WIDE SYSTEM Hiossen, Inc. | DZE |
| Apr 2, 2010 | K093321 | BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM BioHorizons Implant Systems, Inc. | DZE |
| Mar 4, 2010 | K093615 | SPI DENTAL IMPLANT, ELEMENT Thommen Medical AG | DZE |
| Mar 3, 2010 | K091208 | GS III SYSTEM Osstem Implant Co., Ltd. | DZE |
| Feb 18, 2010 | K091678 | HG II SHORT FIXTURE SYSTEM Osstem Implant Co., Ltd. | DZE |
| Feb 12, 2010 | K093027 | STRAUMANN RC TEMPORARY ABUTMENTS Straumann USA | DZE |
| Jan 22, 2010 | K091387 | BTI DENTAL IMPLANT 5.5-6.5 B.T.I. Biotechnology Institute, Sl., ES | DZE |
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