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 14 of 16
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K934668 | ZEST IMPLANT ANCHOR ADVANCED GENERATION (DENTAL) | Zest Anchors, Inc. | 1994-06-22 | Traditional | PDF ↗ |
| K932123 | IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEM | Implant Innovations International, Inc. | 1994-05-27 | Traditional | PDF ↗ |
| K925312 | HAND INSTRUMENT CALCULUS REMOVAL | Implant Support Systems, Inc. | 1994-05-23 | Traditional | PDF ↗ |
| K925796 | SPIRAL LOCK DENTAL IMPLANT SYSTEM | Robert A James | 1994-05-23 | Traditional | PDF ↗ |
| K926100 | SPIRAL LOCK DENTAL IMPLANT SYSTEM | Robert A James | 1994-05-23 | Traditional | PDF ↗ |
| K923694 | DUO DENT | Pdc Management Services, Inc. | 1994-05-18 | Traditional | PDF ↗ |
| K925483 | BRANEMARK SYST. HAND INST. DIA 297 & SDIA 276 | Nobelpharma USA, Inc. | 1994-05-02 | Traditional | PDF ↗ |
| K933969 | TAPERED ABUTMENT AND RELATED COMPONENTS | Implant Innovations, Inc. | 1994-04-26 | Traditional | PDF ↗ |
| K931993 | ITI DISTANCE SYSTEM | The Straumann Co. | 1994-04-26 | Traditional | PDF ↗ |
| K934126 | ONE AND TWO PIECE TEMPORARY HEALING,(EMERGENCE PROFILE) ABUTMENTS | Implant Innovations, Inc. | 1994-04-25 | Traditional | PDF ↗ |
| K921805 | STRYKER PRECISION DENTAL IMPLANT SYSTEM | Stryker Instruments | 1994-03-10 | Traditional | PDF ↗ |
| K933462 | CONICAL ABUTMENT | Implant Innovations, Inc. | 1994-03-07 | Traditional | PDF ↗ |
| K933193 | IMPLA-MED UCLA TYPE ABUTMENTS,SCREWDRIVER,REAMER,L | The Stern Metals Co., Inc. | 1994-03-07 | Traditional | PDF ↗ |
| K926305 | IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETER | The Stern Metals Co., Inc. | 1994-03-01 | Traditional | PDF ↗ |
| K930155 | MINIBALL ABUTMENT | Steri-Oss, Inc. | 1994-02-14 | Traditional | PDF ↗ |
| K924219 | ENDOSSEOUS IMPLANTS | The Stern Metals Co., Inc. | 1994-02-14 | Traditional | PDF ↗ |
| K922732 | INTERPORE CYLINDRICAL HEX IMPLANT, 3.3 MM DIAMETER | Interpore Intl. | 1994-02-10 | Traditional | PDF ↗ |
| K925776 | BRANEMARK SYSTEM INTERLOCKING ABUTMENT/GOLD CYLIND | Nobelpharma USA, Inc. | 1994-02-10 | Traditional | PDF ↗ |
| K931767 | ASTRA TECH IMPLANTS-DENTAL SYSTEM | Astra Tech, Inc. | 1994-02-08 | Traditional | PDF ↗ |
| K914137 | HA-BIONTEGRATED DENTAL IMPLANT SYSTEMS | Lifecore Biomedical, Inc. | 1994-02-03 | Traditional | PDF ↗ |
| K931440 | CALCITEK TORQUE WRENCH SYSTEM | Calcitek, Inc. | 1994-01-26 | Traditional | PDF ↗ |
| K923484 | STERI-OSS TITANIUM SCREW SERIES IMPLANT | Steri-Oss, Inc. | 1993-12-13 | Traditional | PDF ↗ |
| K924121 | STERI-OSS SCREW STYLE ITIANIUM IMPLANT | Steri-Oss, Inc. | 1993-12-10 | Traditional | PDF ↗ |
| K923695 | STERI-OSS SCREW STYLE CP TITANIUM IMPLANT | Steri-Oss, Inc. | 1993-12-10 | Traditional | PDF ↗ |
| K914714 | BONE DRILLS OR TAPS | Implant Corp. of America | 1993-11-15 | Traditional | PDF ↗ |
| K932274 | INTEGRAL III DENTAL IMPLANT ABUTMENT | Calcitek, Inc. | 1993-11-05 | Traditional | PDF ↗ |
| K923562 | INTERGRAL III DENTAL IMPLANT SYSTEM | Calcitek, Inc. | 1993-11-05 | Traditional | PDF ↗ |
| K925767 | BRANEMARK SYSTEM SINGLE TOOTH ABUTMENTS,INST&COMP. | Nobelpharma USA, Inc. | 1993-10-20 | Traditional | PDF ↗ |
| K933150 | NOBLEPHARMA DEC 500 STRAIGHT HANDPIECE | Nobelpharma USA, Inc. | 1993-10-20 | Traditional | PDF ↗ |
| K925762 | BRANEMARK SYSTEM SELF-TAPPING FIXTURE | Nobelpharma USA, Inc. | 1993-10-12 | Traditional | PDF ↗ |
| K925487 | NOBLEPHARMA BRANEMARK SYSTEM GOLD CYLINDERS | Nobelpharma USA, Inc. | 1993-10-12 | Traditional | PDF ↗ |
| K911593 | STERI-OSS DUAL COATED CYLINDRICAL IMPLANTS | Steri-Oss, Inc. | 1993-10-07 | Traditional | PDF ↗ |
| K925765 | BRANEMARK SYSTEM STANDARD 3.75MM FIXTURE | Nobelpharma USA, Inc. | 1993-10-05 | Traditional | PDF ↗ |
| K925761 | BRANEMARK SYSTEM 5.0 X 14MM FIXTURE | Nobelpharma USA, Inc. | 1993-10-05 | Traditional | PDF ↗ |
| K926501 | BRANEMARK SYSTEM(R) - 5.5MM FIXTURE | Nobelpharma USA, Inc. | 1993-10-05 | Traditional | PDF ↗ |
| K925764 | BRANEMARK SYSTEM 4.00 MM FIXTURE | Nobelpharma USA, Inc. | 1993-10-05 | Traditional | PDF ↗ |
| K925760 | BRANEMARK SYSTEM CONICAL SELF-TAPPING FIXTURE | Nobelpharma USA, Inc. | 1993-10-05 | Traditional | PDF ↗ |
| K925774 | BRANEMARK SYSTEM HAND INSTRUMENT | Nobelpharma USA, Inc. | 1993-09-16 | Traditional | PDF ↗ |
| K925770 | BRANEMARK SYSTEM DRILLS AND COUNTERSINKS | Nobelpharma USA, Inc. | 1993-09-16 | Traditional | PDF ↗ |
| K925772 | BRANEMARK SYSTEM GUIDE PINS | Nobelpharma USA, Inc. | 1993-09-16 | Traditional | PDF ↗ |
| K925768 | BRANEMARK SYSTEM SCREW TAP | Nobelpharma USA, Inc. | 1993-09-16 | Traditional | PDF ↗ |
| K925775 | BRANEMARK SYSTEM MACHINE INST. ACC. TO DRILLING EQ | Nobelpharma USA, Inc. | 1993-09-16 | Traditional | PDF ↗ |
| K920452 | THE BRANEMARK SYSTEM BALL ATTACHMENT ABUTMENT SYST | Nobelpharma USA, Inc. | 1993-09-13 | Traditional | PDF ↗ |
| K925313 | TITANIUM COC ABUTMENT HEADS FOR IMZ | Implant Support Systems, Inc. | 1993-07-30 | Traditional | PDF ↗ |
| K922805 | NOBELPHARMA TORQUE CONTROLLER | Nobelpharma USA, Inc. | 1993-07-22 | Traditional | PDF ↗ |
| K911592 | STERI-OSS TITANIUM PLAMA SPRAY CYLINDRICAL IMPLANT | Steri-Oss, Inc. | 1993-07-22 | Traditional | PDF ↗ |
| K924190 | ISS O-RING ATTACHMENT | Implant Support Systems, Inc. | 1993-05-27 | Traditional | PDF ↗ |
| K924155 | SURA SNAP | Metalor Dental USA Corp. | 1993-05-12 | Traditional | PDF ↗ |
| K925778 | BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES | Nobelpharma USA, Inc. | 1993-04-14 | Traditional | PDF ↗ |
| K925780 | BRANEMARK SYSTEM HEALING CAPS | Nobelpharma USA, Inc. | 1993-04-14 | Traditional | PDF ↗ |
| K925771 | BRANEMARK SYSTEM TITANIUM COVER SCREWS | Nobelpharma USA, Inc. | 1993-04-14 | Traditional | PDF ↗ |
| K925773 | BRANEMARK SYSTEM GOLD CYLINDERS AND SCREWS | Nobelpharma USA, Inc. | 1993-04-14 | Traditional | PDF ↗ |
| K925777 | BRANEMARK SYSTEM ESTHETICONE ABUTMENT COMPLETE | Nobelpharma USA, Inc. | 1993-04-14 | Traditional | PDF ↗ |
| K913404 | IMPLANDRILL - THREADED DENTAL IMPLANT | Impladrill , Ltd. | 1993-03-31 | Traditional | PDF ↗ |
| K922779 | IMPLANT-PROPHY & PLASTIC DENTAL INSTRUMENT SYSTEM | Advanced Implant Technologies, Inc. | 1993-01-28 | Traditional | PDF ↗ |
| K920909 | HEXLOCK SCREW | Imtec Corp. | 1993-01-12 | Traditional | PDF ↗ |
| K915865 | AIT IMPLANT SYSTEM | American Implant Technology, Inc. | 1992-11-04 | Traditional | PDF ↗ |
| K921764 | DALLA BONA BALL & SOCKEY ATTACH. SNAP TYPE PRECIS | Implant Support Systems, Inc. | 1992-11-03 | Traditional | PDF ↗ |
| K921854 | IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM | Impla-Med | 1992-10-27 | Traditional | PDF ↗ |
| K913228 | INTERPORE IMZ CYLINDER IMPLANT SYSTEM | Interpore Intl. | 1992-10-13 | Traditional | PDF ↗ |
| K921010 | STERN ERA ALIGNMENT CORRECTION IMPLANT ABUTMENT | Apm Stern Gold | 1992-09-01 | Traditional | PDF ↗ |
| K905434 | ANGULATED ABUTMENT, COMPLETE,TITANIUM SDCA 102 | Nobelpharma USA, Inc. | 1992-08-27 | Traditional | PDF ↗ |
| K911575 | ANCHOR IMPLANT DENTAL ATTACHMENTS | Anchor Implant Systems, Inc. | 1992-08-10 | Traditional | PDF ↗ |
| K915733 | STERI-OSS DRILLS AND TAPS | Steri-Oss, Inc. | 1992-07-17 | Traditional | PDF ↗ |
| K920928 | PRE-STERILIZED ITI DENTAL IMPLANTS | The Straumann Co. | 1992-07-15 | Traditional | PDF ↗ |
| K921933 | O BUTMENT HB | O Co., Inc. | 1992-07-08 | Traditional | PDF ↗ |
| K921246 | IMZ SURGICAL INSTRUMENT TRAY | Interpore Intl. | 1992-06-22 | Traditional | PDF ↗ |
| K915375 | ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEM | Odontit Systeme | 1992-06-03 | Traditional | PDF ↗ |
| K920768 | HOLLOW SCREW IMPLANTS 6MM, 14MM, 16MM | The Straumann Co. | 1992-04-21 | Traditional | PDF ↗ |
| K911735 | ARTECH ARDENT IV - TYPE CLYLINDER IMPLANT | Artech Corp. | 1992-03-05 | Traditional | PDF ↗ |
| K913417 | ETEX DENTAL IMPLANT SYSTEM | Etex Co. | 1992-02-19 | Traditional | PDF ↗ |
| K903999 | OBUTMENT HB | O Co., Inc. | 1992-02-11 | Traditional | PDF ↗ |
| K912059 | PRE-ANGLED ABUTMENTS | Core-Vent Corp. | 1992-02-11 | Traditional | PDF ↗ |
| K915597 | BUR,DENTAL (76EJL) | Calcitek, Inc. | 1992-02-05 | Traditional | PDF ↗ |
| K913348 | THE STERN ERA SYSTEM | Sterngold/Implamed | 1992-01-30 | Traditional | PDF ↗ |
| K902433 | DIA ANATOMIC ABUTMENT | Dental Imaging Assoc., Inc. | 1992-01-17 | Traditional | PDF ↗ |
| K914764 | STERN ERA IMPLANT ABUTMENT | Sterngold/Implamed | 1992-01-17 | Traditional | PDF ↗ |
| K911776 | DPI-1106 IMPLANT, MODIFICATION | Minimatic Implant Technology | 1992-01-15 | Traditional | PDF ↗ |
| K912734 | INTERPORE HEX HEAD IMPLANT RESTORATIVE COMPONENTS | Interpore Intl. | 1992-01-08 | Traditional | PDF ↗ |
| K911960 | BRANEMARK SYSTEM-3.0MM FIXTURE | Nobelpharma USA, Inc. | 1991-12-19 | Traditional | PDF ↗ |
| K912262 | HEXLOCK | Imtec Corp. | 1991-12-10 | Traditional | PDF ↗ |
| K914043 | MIDWEST IMPLANT HEXED 3.75MM STANDARD THREAD IMPLA | Midwest Implant Sales, Inc. | 1991-12-09 | Traditional | PDF ↗ |
| K914042 | MIDWEST IMPLANT HEXED 3.75MM SELF TAPPING IMPLANT | Midwest Implant Sales, Inc. | 1991-12-09 | Traditional | PDF ↗ |
| K904391 | VIDENT IMPAC IMPLANT ACCESSORIES | Vident | 1991-12-09 | Traditional | PDF ↗ |
| K914041 | MIDWEST IMPLANT HEXED 3.3 MM CYLINDER TYPE IMPLANT | Midwest Implant Sales, Inc. | 1991-12-09 | Traditional | PDF ↗ |
| K904236 | ENDOSSEOUS IMPLANTS | Attachments Intl., Inc. | 1991-11-27 | Traditional | PDF ↗ |
| K913782 | TCAL ABUTMENT | Core-Vent Corp. | 1991-10-30 | Traditional | PDF ↗ |
| K910585 | TSIR ANGLED ABUTMENTS | Core-Vent Corp. | 1991-10-04 | Traditional | PDF ↗ |
| K905223 | OCTA-HEX (TM) IMPLANT RESTORATION SYSTEMS | Universal Implant Systems, Inc. | 1991-08-16 | Traditional | PDF ↗ |
| K910611 | NOBELPHARMA CERAONE ABUTMENT SYSTEM | Nobelpharma USA, Inc. | 1991-08-16 | Traditional | PDF ↗ |
| K911961 | BRANEMARK SYSTEM-5.0MM FIXTURE | Nobelpharma USA, Inc. | 1991-07-25 | Traditional | PDF ↗ |
| K904450 | BIOCERAM DENTAL IMPLANT, SERIES II | Kyocera America, Inc. | 1991-07-09 | Traditional | PDF ↗ |
| K902331 | BUD DENTAL IMPLANT SYSTEM | Bud Industries, Inc. | 1991-07-05 | Traditional | PDF ↗ |
| K903515 | HH-1119 HEALING HEAD | Minimatic Implant Technology | 1991-07-04 | Traditional | PDF ↗ |
| K911112 | DEVICE PART NUMBERS: - 1400 SERIES | Minimatic Implant Technology | 1991-06-10 | Traditional | PDF ↗ |
| K885158 | MENSOR COMPLIANT KEEPER | Merrill C. Mensor, Jr., D.D.S. | 1991-06-06 | Traditional | PDF ↗ |
| K902968 | BIO-VENT-X ENDOSSEOUS HA COATED DENTAL IMPLANTS | Core-Vent Corp. | 1991-05-15 | Traditional | PDF ↗ |
| K904707 | BC 1208 IMPLANT, THREADED EXTERNAL HEX | Minimatic Implant Technology | 1991-04-29 | Traditional | PDF ↗ |
| K905039 | IMPLANT, THREADED EXTERNAL HEX, TAPERED SHOULDER | Minimatic Implant Technology | 1991-04-29 | Traditional | PDF ↗ |
| K903043 | ICT-1108 IMPLANT- THREADED (CEMENT TYPE ABUTMENT) | Minimatic Implant Technology | 1991-04-19 | Traditional | PDF ↗ |
Product code DZE · Class II · Dental. Data: openFDA.