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 13 of 16
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K952886 | BRANEMARK SYSTEM OVOID & U-SHAPED BAR SYSTEM | Nobelpharma USA, Inc. | 1995-09-18 | Traditional | PDF ↗ |
| K952685 | BRANEMARK SYSTEM DRILLS AND COUNTERSINKS | Nobelpharma USA, Inc. | 1995-09-18 | Traditional | PDF ↗ |
| K952634 | OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW | Opti-Max | 1995-09-18 | Traditional | PDF ↗ |
| K953281 | HA, TP CYLINDER OVAL | Implant Center of the Palm Beaches | 1995-09-15 | Traditional | PDF ↗ |
| K950066 | DENTAL IMPLANT ENDOSSEOUS | O Co., Inc. | 1995-09-15 | Traditional | PDF ↗ |
| K953237 | PROSTHETICS & INSTRUMENTATION A. PROSTHETIC ABUTMENTS 4, 5, 6 DIAMETER, GRADE 3, B. IRRIGATION DRILLS, TOOLING & PREANG' | The Implant Center of the Palm Beaches | 1995-09-15 | Traditional | PDF ↗ |
| K953280 | HA, TP CYLINDER, UNIHOLE | Implant Center of the Palm Beaches | 1995-09-15 | Traditional | PDF ↗ |
| K953235 | SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3 | The Implant Center of the Palm Beaches | 1995-09-13 | Traditional | PDF ↗ |
| K953236 | CYLINDER IMPLANTS HA, TP, GRADE 3 | The Implant Center of the Palm Beaches | 1995-09-13 | Traditional | PDF ↗ |
| K953139 | KIS-- FOUR HOLE CYLINDER | Implant Center of the Palm Beaches | 1995-09-13 | Traditional | PDF ↗ |
| K953331 | COMBINATION KIT | Steri-Oss, Inc. | 1995-09-08 | Traditional | PDF ↗ |
| K953380 | LABORATORY SUPPLIES | Steri-Oss, Inc. | 1995-09-05 | Traditional | PDF ↗ |
| K950624 | HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM | Lifecore Biomedical, Inc. | 1995-08-30 | Traditional | PDF ↗ |
| K953103 | LAPPING TOOL KIT | Steri-Oss, Inc. | 1995-08-29 | Traditional | PDF ↗ |
| K952676 | BRANEMARK SYSTEM BALL ATTACHMENT SYSTEM | Nobelpharma USA, Inc. | 1995-08-11 | Traditional | PDF ↗ |
| K951609 | IMZ - DENTAL IMPLANT SURGICAL TRAY | Imz, GmbH | 1995-08-01 | Traditional | PDF ↗ |
| K951611 | IMZ - DENTAL IMPLANT SINGLE TOOTH ATTACHMENT | Imz, GmbH | 1995-08-01 | Traditional | PDF ↗ |
| K951614 | IMZ - DENTAL IMPLANT | Imz, GmbH | 1995-07-26 | Traditional | PDF ↗ |
| K951617 | IMZ - DENTAL IMPLANT CASTABLE CSR ATTACHMENT | Imz, GmbH | 1995-07-26 | Traditional | PDF ↗ |
| K951615 | IMZ - DENTAL IMPLANT COMPONENTS | Imz, GmbH | 1995-07-26 | Traditional | PDF ↗ |
| K951610 | IMZ - DENTAL IMPLANT | Imz, GmbH | 1995-07-26 | Traditional | PDF ↗ |
| K952989 | WIDE STR-TP-4K, PROS STR, CLY-STR-TP 4 | Implant Center of the Palm Beaches | 1995-07-26 | Traditional | PDF ↗ |
| K951618 | IMZ - DENTAL IMPLANT O-RING ATTACHMENT | Imz, GmbH | 1995-07-26 | Traditional | PDF ↗ |
| K951612 | IMZ - DENTAL IMPLANT COMPONENTS | Imz, GmbH | 1995-07-26 | Traditional | PDF ↗ |
| K952988 | WIDE SCREWS TP-4K, PROS-G4, TOOLS G4 OR 17-4 SS | Implant Center of the Palm Beaches | 1995-07-26 | Traditional | PDF ↗ |
| K952434 | ENDOPORE DENTAL IMPLANT ABUTMENTS | Innova Corp. | 1995-07-19 | Traditional | PDF ↗ |
| K951606 | KIS-II IMPLANT FIXTURES | Implant Center of the Palm Beaches | 1995-07-14 | Traditional | PDF ↗ |
| K945706 | BONE DRILL | Osteo Implant Corp. | 1995-07-14 | Traditional | PDF ↗ |
| K950578 | SCREW-VENT IMPLANT | Core-Vent Corp. | 1995-07-11 | Traditional | PDF ↗ |
| K950577 | SWEDE-VENT IMPLANT | Core-Vent Corp. | 1995-07-11 | Traditional | PDF ↗ |
| K950579 | MICRO-VENT IMPLANT | Core-Vent Corp. | 1995-07-11 | Traditional | PDF ↗ |
| K950575 | BIO-VENT IMPLANT | Core-Vent Corp. | 1995-07-11 | Traditional | PDF ↗ |
| K950576 | BIO-VENT X IMPLANT | Core-Vent Corp. | 1995-07-11 | Traditional | PDF ↗ |
| K951553 | 3I ASYST ABUTMENT PACKAGE SYSTEM | Implant Innovations, Inc. | 1995-06-30 | Traditional | PDF ↗ |
| K952644 | STERI-OSS SELF TAPING IMPLANT | Steri-Oss, Inc. | 1995-06-23 | Traditional | PDF ↗ |
| K952120 | TORQUE LIMITER | Steri-Oss, Inc. | 1995-06-22 | Traditional | PDF ↗ |
| K952448 | 3.3MM ACCESSORIES | Nobelpharma USA, Inc. | 1995-06-20 | Traditional | PDF ↗ |
| K946198 | IMPLA-MED LOW MARGIN ABUTMENTS, SCREWDRIVER, POLISHING PROTECTOR | Sterngold | 1995-06-14 | Traditional | PDF ↗ |
| K941393 | ITI ANGLED ABUTMENT | The Straumann Co. | 1995-06-14 | Traditional | PDF ↗ |
| K951065 | SURGICAL INSTRUMENT MOTOTRS AND ACCESSORIES/ATTACHMENTS | Steri-Oss, Inc. | 1995-06-08 | Traditional | PDF ↗ |
| K951937 | BIOPATH SELF-TAPPING DENTAL IMPLANT SYSTEM (5MM, 6MM) | Bio Path | 1995-06-05 | Traditional | PDF ↗ |
| K952193 | OSTEOTOMES | Steri-Oss, Inc. | 1995-06-02 | Traditional | PDF ↗ |
| K944327 | INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM | Calcitek, Inc. | 1995-05-16 | Traditional | PDF ↗ |
| K941608 | INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RING | Calcitek, Inc. | 1995-05-05 | Traditional | PDF ↗ |
| K950893 | KIS-V PRE-ANGULATED AND WIDE BODY ABUTMENTS | The Implant Center of the Palm Beaches | 1995-05-05 | Traditional | PDF ↗ |
| K950446 | BONE CUTTING INSTRUMENT AND ACCESSORIES | Steri-Oss, Inc. | 1995-05-03 | Traditional | PDF ↗ |
| K912521 | DENTAL IMPLANT SYSTEM 4.0MM AND 5.5MM LENGTH | Bud Industries, Inc. | 1995-05-02 | Traditional | PDF ↗ |
| K930868 | DYNA IMPLANT DESIGN | Dyna Dental Engineering BV | 1995-04-28 | Traditional | PDF ↗ |
| K944725 | KIS-II STR FIXTURES | Implant Center of the Palm Beaches | 1995-04-26 | Traditional | PDF ↗ |
| K950936 | BONE CUTTING INSTRUMENT AND ACCESSORIES | Steri-Oss, Inc. | 1995-04-20 | Traditional | PDF ↗ |
| K943681 | STERI-OSS SCALER FOR DENTAL IMPLANTS | Steri-Oss, Inc. | 1995-04-14 | Traditional | PDF ↗ |
| K945398 | BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE | Nobelpharma USA, Inc. | 1995-04-13 | Traditional | PDF ↗ |
| K951111 | RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM) | Lifecore Biomedical, Inc. | 1995-03-31 | Traditional | PDF ↗ |
| K944158 | STERI-OSS TITANIUM ALLOY SCREW SERIES IMPLANT FOR SINGLE STAGE SURGICAL PLACEMENT | Steri-Oss, Inc. | 1995-03-29 | Traditional | PDF ↗ |
| K943720 | ITI TRANSVERSAL SCREWING SYSTEM | The Straumann Co. | 1995-03-24 | Traditional | PDF ↗ |
| K935544 | 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION | Implant Innovations International, Inc. | 1995-03-13 | Traditional | PDF ↗ |
| K944943 | OPTI-MAX PRESS-FIT EXTERNAL-HEX DENTAL | Opti-Max | 1995-03-13 | Traditional | PDF ↗ |
| K944683 | BRANEMARK SYSTEM 3.3MM FIXTURE | Nobelpharma USA, Inc. | 1995-03-08 | Traditional | PDF ↗ |
| K943984 | KIS-II NON-ANGULATED ABUTMENTS | Implant Center of the Palm Beaches | 1995-03-01 | Traditional | PDF ↗ |
| K943971 | KIS-II IMPLANT FIXTURES | Implant Center of the Palm Beaches | 1995-03-01 | Traditional | PDF ↗ |
| K946113 | IMPLANT BODY RETRIEVER/REMOVER | O Co., Inc. | 1995-03-01 | Traditional | PDF ↗ |
| K946129 | IMPLANT BODY DEPTH GAUGE/TRYIN | O Co., Inc. | 1995-03-01 | Traditional | PDF ↗ |
| K944964 | BRANEMARK SYSTEM MIRUSCONE ABUTMENT SYSTEM | Nobelpharma USA, Inc. | 1995-02-28 | Traditional | PDF ↗ |
| K944069 | RESTORE TPS LHEX CYLINDER ENDOSSEOUS IMPLANT SYSTEM | Lifecore Biomedical, Inc. | 1995-02-28 | Traditional | PDF ↗ |
| K944962 | BRANEMARK SYSTEM 17 ANGULATED ABUTMENT | Nobelpharma USA, Inc. | 1995-02-27 | Traditional | PDF ↗ |
| K944963 | BRANEMARK SYSTEM SMILINE II | Nobelpharma USA, Inc. | 1995-02-17 | Traditional | PDF ↗ |
| K944904 | PARRALLEL PIN | O Co., Inc. | 1995-02-16 | Traditional | PDF ↗ |
| K945300 | ACCESSORY ITEM TO ENDOSSEOUS DENTAL IMPLANT | O Co., Inc. | 1995-02-16 | Traditional | PDF ↗ |
| K926354 | ENDO-PORE ENDOSSEOUS DENTAL IMPLANT SYSTEM | Innova Corp. | 1995-02-13 | Traditional | PDF ↗ |
| K944068 | RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM) | Lifecore Biomedical, Inc. | 1995-02-02 | Traditional | PDF ↗ |
| K944356 | KIS-II IMPLANT SYSTEM/DRILLS | Implant Center of the Palm Beaches | 1994-12-05 | Traditional | PDF ↗ |
| K923395 | VIDENT IMPAC IMPLANT ACCESSORIES | Vident | 1994-11-22 | Traditional | PDF ↗ |
| K940998 | IMPAC TORQUE WRENCH | Vident | 1994-11-21 | Traditional | PDF ↗ |
| K941247 | VIDENT IMPAC INFINITE POSITION ABUTMENT | Vident | 1994-11-21 | Traditional | PDF ↗ |
| K925849 | ZEST IMPLANT ANCHOR | Zest Anchors, Inc. | 1994-11-18 | Traditional | PDF ↗ |
| K941575 | SMOOTH FIT | Hi-Tec Implants | 1994-11-17 | Traditional | PDF ↗ |
| K941620 | LORENZ SURGICAL CYLINDER DENTAL IMPLANT | Biomet, Inc. | 1994-09-29 | Traditional | PDF ↗ |
| K941621 | LORENZ SURGICAL FINNED DENTAL IMPLANT | Biomet, Inc. | 1994-09-29 | Traditional | PDF ↗ |
| K941619 | LORENZ SURGICAL THREADED DENTAL IMPLANT | Biomet, Inc. | 1994-09-29 | Traditional | PDF ↗ |
| K933532 | SELF TAPPING DENTAL IMPLANT SYSTEM | Implant Support Systems, Inc. | 1994-09-21 | Traditional | PDF ↗ |
| K925555 | STERI-OSS THREADED TPS HEX SERIES IMPLANT | Steri-Oss, Inc. | 1994-09-19 | Traditional | PDF ↗ |
| K925481 | STERI-OSS TITANIUM PLASMA SPRAY SERIES IMPLANT | Steri-Oss, Inc. | 1994-09-19 | Traditional | PDF ↗ |
| K923889 | O BUTMENT ES IMPLANT | O Co., Inc. | 1994-08-29 | Traditional | PDF ↗ |
| K932168 | HEXLOCK/HEXLOCK SCREW | Imtec Corp. | 1994-08-24 | Traditional | PDF ↗ |
| K931785 | BRANEMARK SYSTEM DRILL CONTROLLER | Nobelpharma USA, Inc. | 1994-08-09 | Traditional | PDF ↗ |
| K934827 | BRANEMARK SYSTEM ESTHETICONE NON-ROTATIONAL SYSTEM | Nobelpharma USA, Inc. | 1994-08-08 | Traditional | PDF ↗ |
| K934825 | BRANEMARK SYSTEM | Nobelpharma USA, Inc. | 1994-08-08 | Traditional | PDF ↗ |
| K934495 | BRANEMARK SYSTEM(R) UCLA-TYPE ABUTMENT COMPLETE | Nobelpharma AB | 1994-08-08 | Traditional | PDF ↗ |
| K934826 | BRANEMARK-HEALING CAPS, DCC045, DCC046, DCC104 | Nobelpharma USA, Inc. | 1994-08-08 | Traditional | PDF ↗ |
| K913255 | CERAMIC(TM) ABUTMENT | Ceramic Core Corp. | 1994-08-05 | Traditional | PDF ↗ |
| K925766 | BRANEMARK SYSTEM TEMPORARY SOLUTIONS | Nobelpharma USA, Inc. | 1994-08-02 | Traditional | PDF ↗ |
| K925490 | INTEGRAL III BIOINTEGRATED DENTAL IMPLANT SYSTEM | Calcitek, Inc. | 1994-08-01 | Traditional | PDF ↗ |
| K922872 | INTERPORE CYLINDRICAL HEX HYDROXYAPATITE COATED IMPLANT, 3.3 MM DIAM. | Interpore Intl. | 1994-07-25 | Traditional | PDF ↗ |
| K941554 | SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEM | Lifecore Biomedical, Inc. | 1994-07-22 | Traditional | PDF ↗ |
| K931468 | RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM | Lifecore Biomedical, Inc. | 1994-07-12 | Traditional | PDF ↗ |
| K924112 | HYDROXYLAPATITE COATED SABER TECH SERIES I & SERIES II | Saber Technology, Inc. | 1994-07-12 | Traditional | PDF ↗ |
| K930071 | SARGON CYLINDRO-BLADE IMPLANT | Sargon Ent., Inc. | 1994-07-08 | Traditional | PDF ↗ |
| K926101 | PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDRO | Phoenix Dental, Inc. | 1994-06-23 | Traditional | PDF ↗ |
| K926102 | PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN | Phoenix Dental, Inc. | 1994-06-22 | Traditional | PDF ↗ |
| K924589 | RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM | Implant Support Systems, Inc. | 1994-06-22 | Traditional | PDF ↗ |
Product code DZE · Class II · Dental. Data: openFDA.