FDA Product Code
FDA Product Code DZE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3640
510(k) Clearances — 1,549 records · page 10 of 16
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K022562 | VARIOUS BRANEMARK SYSTEM IMPLANTS-IMMEDIATE FUNCTION INDICATION | Nobel Biocare AB | 2002-10-11 | Traditional | PDF ↗ |
| K023336 | OCO DENTAL IMPLANT (5.0MM DIAMETER) | O Co., Inc. | 2002-10-09 | Special | PDF ↗ |
| K022424 | REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162 | Nobel Biocare Uas, Inc. | 2002-09-27 | Traditional | PDF ↗ |
| K023113 | REPLACE TIUNITE ENDOSSEOUS IMPLANT | Nobel Biocare Uas, Inc. | 2002-09-26 | Special | PDF ↗ |
| K022912 | POST AND CORE - THIN FOR THE BASIC DENTAL IMPLANT SYSTEM | Basic Dental Implant Systems, Inc. | 2002-09-20 | Special | PDF ↗ |
| K022859 | ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM | Straumann USA | 2002-09-19 | Special | PDF ↗ |
| K022113 | 3I DENTAL IMPLANT ACCESSORIES | Implant Innovations, Inc. | 2002-09-19 | Traditional | PDF ↗ |
| K012473 | VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT | Vident | 2002-09-11 | Traditional | PDF ↗ |
| K021355 | ENDOSSEOUS IMPLANT | Branemark Integration AB | 2002-08-30 | Traditional | PDF ↗ |
| K011879 | 3A DENTAL IMPLANT SYSTEM | Osseco Biosource, Ltd. | 2002-08-27 | Traditional | PDF ↗ |
| K022425 | SCREWLINE | Altatec Biotechnologies N.A., Inc. | 2002-08-14 | Special | PDF ↗ |
| K021322 | ENDOSSOUS IMPLANTS | Intra-Lock International | 2002-07-24 | Abbreviated | PDF ↗ |
| K022038 | SPI ONETIME DENTAL IMPLANT | Paxmed International | 2002-07-15 | Special | PDF ↗ |
| K021318 | XIVE DENTAL IMPLANT SYSTEM | Friadent GmbH | 2002-07-02 | Traditional | PDF ↗ |
| K021045 | ERA IMPLANT | Sterngold | 2002-06-26 | Abbreviated | PDF ↗ |
| K021833 | MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM | Blue Sky Bio | 2002-06-10 | Special | PDF ↗ |
| K021584 | REPLACE SCALLOPED MARGIN IMPLANT SYSTEM | Nobel Biocare Uas, Inc. | 2002-06-05 | Special | PDF ↗ |
| K010132 | KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4 | SOADCO, S.L. | 2002-06-04 | Traditional | PDF ↗ |
| K020646 | REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162 | Nobel Biocare Uas, Inc. | 2002-05-29 | Traditional | PDF ↗ |
| K014235 | OSSEOTITE NT DENTAL IMPLANTS & ACCESSORIES | Implant Innovations, Inc. | 2002-05-16 | Traditional | PDF ↗ |
| K020617 | NSI HEXED AND NON-HEXED IMPLANT SYSTEM | Nsi | 2002-05-10 | Traditional | PDF ↗ |
| K021244 | ACE HA SCREW DENTAL IMPLANT SYSTEM | Ace Surgical Supply Co., Inc. | 2002-05-03 | Special | PDF ↗ |
| K011524 | IMMEDIATE STABILIZING DEVICE (ISD) | O Co., Inc. | 2002-04-10 | Traditional | PDF ↗ |
| K013067 | FRIALOC DENTAL IMPLANT SYSTEM | Friadent GmbH | 2002-04-09 | Traditional | PDF ↗ |
| K014214 | SULZER DENTAL CERAMIC SYSTEM-SPLINE | Sulzer Dental, Inc. | 2002-03-19 | Traditional | PDF ↗ |
| K013867 | XIVE DENTAL IMPLANT SYSTEM | Friadent GmbH | 2002-03-15 | Traditional | PDF ↗ |
| K020645 | MODIFICATION TO THE MAESTRO SYSTEM | BioHorizons Implant Systems, Inc. | 2002-03-15 | Special | PDF ↗ |
| K020391 | STERN MICRO ERA ATTACHMENT SYSTEM | Sterngold | 2002-03-08 | Special | PDF ↗ |
| K001638 | O-RING PROSTHETIC ATTACHMENT | Titan Implants | 2002-03-04 | Traditional | PDF ↗ |
| K020096 | ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM | Institut Straumann AG | 2002-02-08 | Special | PDF ↗ |
| K013891 | SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT | Institut Straumann AG | 2002-02-05 | Special | PDF ↗ |
| K020133 | MODIFICATION TO THE MAESTRO SYSTEM | BioHorizons Implant Systems, Inc. | 2002-01-25 | Special | PDF ↗ |
| K013494 | 3.75MM AND 5.0MM SPLINE TWIST IMPLANT | Sulzer Dental, Inc. | 2002-01-18 | Traditional | PDF ↗ |
| K013383 | BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM | Biomedical Implant Technology, Inc. | 2002-01-10 | Traditional | PDF ↗ |
| K013438 | FRIALIT-2 ESTHETICBASE ABUTMENT | Friadent GmbH | 2001-12-20 | Traditional | PDF ↗ |
| K013798 | PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM | Institut Straumann AG | 2001-12-19 | Traditional | PDF ↗ |
| K981052 | CRESCO TI IMPLANT CONCEPT | Cresco TI Systems AB | 2001-12-18 | Traditional | PDF ↗ |
| K013570 | OSSEOTITE DENTAL IMPLANTS | Implant Innovations, Inc. | 2001-12-17 | Special | PDF ↗ |
| K013682 | MODIFICATION TO BASIC DENTAL IMPLANT SYSTEM | Basic Dental Implant Systems, Inc. | 2001-11-28 | Special | PDF ↗ |
| K013227 | SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT | Sulzer Dental, Inc. | 2001-11-19 | Traditional | PDF ↗ |
| K011502 | CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM | Crystal-Seal Dental Implants | 2001-10-22 | Traditional | PDF ↗ |
| K003191 | MIS IMPLANT SYSTEM DECIVE | Mis Implants Technologies , Ltd. | 2001-09-28 | Traditional | PDF ↗ |
| K012911 | 3I LOCATER ABUTMENT SYSTEM | Implant Innovations, Inc. | 2001-09-28 | Traditional | PDF ↗ |
| K010882 | BLUE SKY BIO DENTAL IMPLANT SYSTEM | Blue Sky Bio | 2001-09-28 | Traditional | PDF ↗ |
| K010467 | UNIVERSAL DENTAL COPING (UDC) | Paxmed International | 2001-09-28 | Traditional | PDF ↗ |
| K000035 | OMNICARE DENTAL IMPLANT SYSTEM | Omnicare Dental Implant Center | 2001-09-28 | Traditional | PDF ↗ |
| K010619 | UCLA AND UNIVERSAL ABUTMENTS | Diamodent | 2001-09-28 | Traditional | PDF ↗ |
| K011574 | UNIPLANT DENTAL IMPLANT SYSTEM | Universal Implant Systems, Inc. | 2001-09-28 | Traditional | PDF ↗ |
| K991250 | QUANTUM VERSATILITY IMPLANT SYSTEM | Quantum Bioengineering, Ltd. | 2001-09-20 | Traditional | PDF ↗ |
| K011223 | QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM | Paxmed International | 2001-09-20 | Traditional | PDF ↗ |
| K002241 | QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM | Quantum Bioengineering, Ltd. | 2001-09-20 | Traditional | PDF ↗ |
| K003620 | NSI HEXED AND NON-HEXED IMPLANT SYSTEM | Nsi | 2001-09-19 | Traditional | PDF ↗ |
| K012055 | 3.25MM SPLINE TWIST IMPLANT | Sulzer Dental, Inc. | 2001-09-06 | Traditional | PDF ↗ |
| K012757 | ITI DENTAL IMPLANT SYSTEM | Straumann USA | 2001-08-22 | Special | PDF ↗ |
| K003552 | ITI DENTAL IMPLANT SYSTEM | Institut Straumann SA | 2001-08-17 | Traditional | PDF ↗ |
| 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 | 2001-08-15 | Traditional | PDF ↗ |
| K012299 | MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DENTAL IMPLANT SYSTEM | Basic Dental Implant Systems, Inc. | 2001-08-01 | Special | PDF ↗ |
| K003045 | HA-TI (HAND TITANIUM SCREW) IMPLANT | Hati Dental Ag. | 2001-07-12 | Traditional | PDF ↗ |
| K003818 | TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS | Titan Implants | 2001-07-05 | Traditional | PDF ↗ |
| K011245 | ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM | Sulzer Dental, Inc. | 2001-06-25 | Traditional | PDF ↗ |
| K011028 | SCREW-VENT DENTAL IMPLANT SYSTEM | Sulzer Dental, Inc. | 2001-05-21 | Traditional | PDF ↗ |
| K002037 | LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS | Lifecore Biomedical, Inc. | 2001-05-16 | Traditional | PDF ↗ |
| K011038 | TAPER-LOCK DENTAL IMPLANT SYSTEM | Sulzer Dental, Inc. | 2001-05-15 | Traditional | PDF ↗ |
| K010291 | ITI DENTAL IMPLANT SYSTEM | Straumann USA | 2001-05-10 | Traditional | PDF ↗ |
| K010458 | THE MAESTRO SYSTEM | BioHorizons Implant Systems, Inc. | 2001-05-10 | Traditional | PDF ↗ |
| K000889 | SENOJ IMPLANT SYSTEM | Senoj Biocare, Inc. | 2001-04-27 | Traditional | PDF ↗ |
| K003271 | MODIFICATION TO ITI DENTAL IMPLANT SYSTEM | Institut Straumann AG | 2001-03-20 | Traditional | PDF ↗ |
| K010386 | DUO-DENT DENTAL IMPLANT | Duo-Dent Dental Implant Systems, LLC | 2001-02-27 | Special | PDF ↗ |
| 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 | 2001-02-14 | Traditional | PDF ↗ |
| K002075 | ACE SDS 3.75MM SCREW DENTAL IMPLANT | Ace Surgical Supply Co., Inc. | 2001-02-02 | Traditional | PDF ↗ |
| K010142 | OCO DENTAL IMPLANT | O Co., Inc. | 2001-02-01 | Special | PDF ↗ |
| K010073 | SPLINE DENTAL IMPLANT SYSTEM | Sulzer Calcitek, Inc. | 2001-01-19 | Special | PDF ↗ |
| K003226 | THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM | Lifecore Biomedical, Inc. | 2001-01-12 | Traditional | PDF ↗ |
| K001259 | 2-PIECE POST AND CORE FOR THE B.A.S.I.C. DENTAL IMPLANT SYSTEM | Basic Dental Implant Systems, Inc. | 2001-01-12 | Traditional | PDF ↗ |
| K002513 | ASTRA TECH IMPLANTS - DENTAL SYSTEM | Astra Tech, Inc. | 2001-01-04 | Traditional | PDF ↗ |
| K002614 | ADVENT IMPLANT SYSTEM | Core-Vent Corp. | 2000-12-08 | Traditional | PDF ↗ |
| K002475 | REPLACE TPS COATED IMPLANTS | Nobel Biocare Uas, Inc. | 2000-11-09 | Traditional | PDF ↗ |
| K002374 | ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT | Straumann USA | 2000-11-01 | Traditional | PDF ↗ |
| 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. | 2000-10-30 | Traditional | PDF ↗ |
| K000643 | INPLANT ORTHODONTIC ANCHOR SYSTEM | Nobel Biocare Uas, Inc. | 2000-09-07 | Traditional | PDF ↗ |
| K001786 | TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG | Sulzer Calcitek, Inc. | 2000-06-21 | Special | PDF ↗ |
| K994174 | FRIALIT-2 MH-2 ABUTMENT | Friadent GmbH | 2000-04-20 | Traditional | PDF ↗ |
| K000018 | BRANEMARK NOVUM | Nobel Biocare Uas, Inc. | 2000-03-30 | Traditional | PDF ↗ |
| K993129 | UCLA/UNIVERSAL ABUTMENT | Diamodent | 2000-03-28 | Traditional | PDF ↗ |
| K994376 | FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA | Friadent GmbH | 2000-03-24 | Traditional | PDF ↗ |
| K994119 | SYNOCTA ANGLED ABUTMENTS | Straumann USA | 2000-03-17 | Traditional | PDF ↗ |
| K994257 | LOCATOR IMPLANT ANCHOR | Zest Anchors, Inc. | 2000-03-17 | Traditional | PDF ↗ |
| K993894 | LIFECORE SINGLE TOOTH ABUTMENT SYSTEM | Lifecore Biomedical, Inc. | 2000-03-08 | Traditional | PDF ↗ |
| K994205 | MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM | Lifecore Biomedical, Inc. | 2000-02-29 | Traditional | PDF ↗ |
| K992937 | DENTAL IMPLANT | Nobel Biocare Uas, Inc. | 2000-02-29 | Traditional | PDF ↗ |
| K000099 | CAMLOG SCREW IMPLANT SYSTEM | Altatec Biotechnologies | 2000-01-28 | Special | PDF ↗ |
| K984297 | MAGNA ABUTMENT | Factor, Ii, Inc. | 2000-01-28 | Traditional | PDF ↗ |
| K993595 | NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMEDIATE LOADING UPON PLACEMENT) | Nobel Biocare Uas, Inc. | 2000-01-28 | Traditional | PDF ↗ |
| K000065 | CAMLOG CYLINDER IMPLANT SYSTEM | Altatec Biotechnologies | 2000-01-28 | Special | PDF ↗ |
| K000100 | CAMLOG ROOTFORM IMPLANT SYSTEM | Altatec Biotechnologies | 2000-01-28 | Special | PDF ↗ |
| K994037 | THE 4.5MM DIAMETER BICON DENTAL IMPLANT | Bicon, Inc. | 2000-01-11 | Traditional | PDF ↗ |
| K993560 | FRIALIT-2 BONE PROFILER | Friadent GmbH | 2000-01-10 | Traditional | PDF ↗ |
| K993095 | FRIALIT-2 SELECT COMPONENTS | Friadent GmbH | 1999-12-09 | Traditional | PDF ↗ |
| K992538 | AMORPHOUS DIAMOND COATED SCREW | Nobel Biocare Uas, Inc. | 1999-11-23 | Traditional | PDF ↗ |
| K992512 | ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION CORPORATION NTR-3.3 MM SELF-TAPPING HA COA | Imcor | 1999-11-01 | Traditional | PDF ↗ |
Product code DZE · Class II · Dental. Data: openFDA.