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 20, 2001 | K011223 | QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM Paxmed International | DZE |
| Sep 20, 2001 | K002241 | QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM Quantum Bioengineering, Ltd. | DZE |
| Sep 19, 2001 | K003620 | NSI HEXED AND NON-HEXED IMPLANT SYSTEM Nsi | DZE |
| Sep 6, 2001 | K012055 | 3.25MM SPLINE TWIST IMPLANT Sulzer Dental, Inc. | DZE |
| Aug 22, 2001 | K012757 | ITI DENTAL IMPLANT SYSTEM Straumann USA | DZE |
| Aug 17, 2001 | K003552 | ITI DENTAL IMPLANT SYSTEM Institut Straumann SA | DZE |
| Aug 15, 2001 | K991822 | ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT IMPLANT SYSTEM, LONG NECK, MODEL STI RT LN LENGTH Dr. Ihde Dental AG Switzerland | DZE |
| Aug 1, 2001 | K012299 | MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DENTAL IMPLANT SYSTEM Basic Dental Implant Systems, Inc. | DZE |
| Jul 12, 2001 | K003045 | HA-TI (HAND TITANIUM SCREW) IMPLANT Hati Dental Ag. | DZE |
| Jul 5, 2001 | K003818 | TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS Titan Implants | DZE |
| Jun 25, 2001 | K011245 | ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM Sulzer Dental, Inc. | DZE |
| May 21, 2001 | K011028 | SCREW-VENT DENTAL IMPLANT SYSTEM Sulzer Dental, Inc. | DZE |
| May 16, 2001 | K002037 | LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS Lifecore Biomedical, Inc. | DZE |
| May 15, 2001 | K011038 | TAPER-LOCK DENTAL IMPLANT SYSTEM Sulzer Dental, Inc. | DZE |
| May 10, 2001 | K010458 | THE MAESTRO SYSTEM BioHorizons Implant Systems, Inc. | DZE |
| May 10, 2001 | K010291 | ITI DENTAL IMPLANT SYSTEM Straumann USA | DZE |
| Apr 27, 2001 | K000889 | SENOJ IMPLANT SYSTEM Senoj Biocare, Inc. | DZE |
| Mar 20, 2001 | K003271 | MODIFICATION TO ITI DENTAL IMPLANT SYSTEM Institut Straumann AG | DZE |
| Feb 27, 2001 | K010386 | DUO-DENT DENTAL IMPLANT Duo-Dent Dental Implant Systems, LLC | DZE |
| Feb 14, 2001 | K010343 | BMR DENTAL IMPLANT SYSTEM, MODEL 3.3XX, EITHER HA OR TPS COATED, 3.308, 3.310,3.312, 3.314 3.316 Buck Medical Research | DZE |
| Feb 2, 2001 | K002075 | ACE SDS 3.75MM SCREW DENTAL IMPLANT Ace Surgical Supply Co., Inc. | DZE |
| Feb 1, 2001 | K010142 | OCO DENTAL IMPLANT O Co., Inc. | DZE |
| Jan 19, 2001 | K010073 | SPLINE DENTAL IMPLANT SYSTEM Sulzer Calcitek, Inc. | DZE |
| Jan 12, 2001 | K003226 | THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM Lifecore Biomedical, Inc. | DZE |
| Jan 12, 2001 | K001259 | 2-PIECE POST AND CORE FOR THE B.A.S.I.C. DENTAL IMPLANT SYSTEM Basic Dental Implant Systems, Inc. | DZE |
| Jan 4, 2001 | K002513 | ASTRA TECH IMPLANTS - DENTAL SYSTEM Astra Tech, Inc. | DZE |
| Dec 8, 2000 | K002614 | ADVENT IMPLANT SYSTEM Core-Vent Corp. | DZE |
| Nov 9, 2000 | K002475 | REPLACE TPS COATED IMPLANTS Nobel Biocare Uas, Inc. | DZE |
| Nov 1, 2000 | K002374 | ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT Straumann USA | DZE |
| Oct 30, 2000 | K002188 | SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/OPAR,OPB 8,10,12,14/OP2.3D/OP2.8D, Core-Vent Corp. | DZE |
| Sep 7, 2000 | K000643 | INPLANT ORTHODONTIC ANCHOR SYSTEM Nobel Biocare Uas, Inc. | DZE |
| Jun 21, 2000 | K001786 | TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG Sulzer Calcitek, Inc. | DZE |
| Apr 20, 2000 | K994174 | FRIALIT-2 MH-2 ABUTMENT Friadent GmbH | DZE |
| Mar 30, 2000 | K000018 | BRANEMARK NOVUM Nobel Biocare Uas, Inc. | DZE |
| Mar 28, 2000 | K993129 | UCLA/UNIVERSAL ABUTMENT Diamodent | DZE |
| Mar 24, 2000 | K994376 | FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA Friadent GmbH | DZE |
| Mar 17, 2000 | K994257 | LOCATOR IMPLANT ANCHOR Zest Anchors, Inc. | DZE |
| Mar 17, 2000 | K994119 | SYNOCTA ANGLED ABUTMENTS Straumann USA | DZE |
| Mar 8, 2000 | K993894 | LIFECORE SINGLE TOOTH ABUTMENT SYSTEM Lifecore Biomedical, Inc. | DZE |
| Feb 29, 2000 | K994205 | MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM Lifecore Biomedical, Inc. | DZE |
| Feb 29, 2000 | K992937 | DENTAL IMPLANT Nobel Biocare Uas, Inc. | DZE |
| Jan 28, 2000 | K993595 | NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMEDIATE LOADING UPON PLACEMENT) Nobel Biocare Uas, Inc. | DZE |
| Jan 28, 2000 | K984297 | MAGNA ABUTMENT Factor, Ii, Inc. | DZE |
| Jan 28, 2000 | K000100 | CAMLOG ROOTFORM IMPLANT SYSTEM Altatec Biotechnologies | DZE |
| Jan 28, 2000 | K000099 | CAMLOG SCREW IMPLANT SYSTEM Altatec Biotechnologies | DZE |
| Jan 28, 2000 | K000065 | CAMLOG CYLINDER IMPLANT SYSTEM Altatec Biotechnologies | DZE |
| Jan 11, 2000 | K994037 | THE 4.5MM DIAMETER BICON DENTAL IMPLANT Bicon, Inc. | DZE |
| Jan 10, 2000 | K993560 | FRIALIT-2 BONE PROFILER Friadent GmbH | DZE |
| Dec 9, 1999 | K993095 | FRIALIT-2 SELECT COMPONENTS Friadent GmbH | DZE |
| Nov 23, 1999 | K992538 | AMORPHOUS DIAMOND COATED SCREW Nobel Biocare Uas, Inc. | DZE |
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