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 12 of 16
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K963951 | AS 123 PROSTHETIC INSTRUMENTATION SYSTEM | BioHorizons Implant Systems, Inc. | 1996-12-31 | Traditional | PDF ↗ |
| K961665 | O BUTMENT ET IMPLANT | O Co., Inc. | 1996-11-15 | Traditional | PDF ↗ |
| K960868 | B.A.S.I.C. DENTAL IMPLANT SYSTEM | Danlin Products, Inc. | 1996-11-14 | Traditional | PDF ↗ |
| K963224 | STERI-OSS IMPLANTS FOR SINGLE STAGE PLACEMENT | Steri-Oss, Inc. | 1996-11-14 | Traditional | PDF ↗ |
| K963121 | FIXTURE MOUNT KIT | Steri-Oss, Inc. | 1996-11-05 | Traditional | PDF ↗ |
| K963401 | TPS APICAL IMPLANT | Steri-Oss, Inc. | 1996-11-05 | Traditional | PDF ↗ |
| K962014 | 3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC. | Implant Innovations, Inc. | 1996-10-18 | Traditional | PDF ↗ |
| K962844 | REPLACE TPS COATED IMPLANTS | Steri-Oss, Inc. | 1996-10-18 | Traditional | PDF ↗ |
| K962845 | REPLACE HA COATED IMPLANTS | Steri-Oss, Inc. | 1996-10-18 | Traditional | PDF ↗ |
| K962610 | DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES | Implant Integration Systems, Inc. | 1996-10-18 | Traditional | PDF ↗ |
| K962394 | IMPLANT INTEGRATION SYSTEMS DRILLS AND TAPS | Implant Integration Systems, Inc. | 1996-10-11 | Traditional | PDF ↗ |
| K962647 | ANGLED ABUTMENT | Straumann USA | 1996-10-07 | Traditional | PDF ↗ |
| K961382 | MT1A | The Emerging Technologies Group | 1996-09-25 | Traditional | PDF ↗ |
| K961387 | MT-X | The Emerging Technologies Group | 1996-09-25 | Traditional | PDF ↗ |
| K961385 | MT-3A | The Emerging Technologies Group | 1996-09-25 | Traditional | PDF ↗ |
| K961383 | MT1 | The Emerging Technologies Group | 1996-09-25 | Traditional | PDF ↗ |
| K961384 | MT-2 | The Emerging Technologies Group | 1996-09-25 | Traditional | PDF ↗ |
| K961386 | MT-2A | The Emerging Technologies Group | 1996-09-25 | Traditional | PDF ↗ |
| K962465 | TIL313 ABUTMENT AND RETAINING SCREW SYSTEMS | Implant Innovations, Inc. | 1996-09-20 | Traditional | PDF ↗ |
| K962403 | NOBLEPHARMA WIDE ACCESSORIES | Nobelpharma USA, Inc. | 1996-09-06 | Traditional | PDF ↗ |
| K962449 | OSTEO COMPACTION KIT | Steri-Oss, Inc. | 1996-09-06 | Traditional | PDF ↗ |
| K962106 | SPLINE DENTAL IMPLANT SYSTEMS | Calcitek, Inc. | 1996-08-29 | Traditional | PDF ↗ |
| K961861 | VARIOUS DENTAL IMPLANTS WITH COVER SCREWS | Implant Management of America | 1996-08-22 | Traditional | PDF ↗ |
| K962023 | PLASTIC PROTECTION HEALING CAPS | The Straumann Co. | 1996-08-15 | Traditional | PDF ↗ |
| K960417 | 3I STND THREADED/SELF TAPPING THREADED/3I MINIPLANT IMPLANTS/3 I EMERGENCE PROF. TEMP. HEALING ABUTMENTS | Implant Innovations, Inc. | 1996-08-01 | Traditional | PDF ↗ |
| K960398 | STERI-OSS APICAL IMPLANT | Steri-Oss, Inc. | 1996-08-01 | Traditional | PDF ↗ |
| K960886 | STERI-OSS 6 MM DIAMETER HA COATED IMPLANTS | Steri-Oss, Inc. | 1996-08-01 | Traditional | PDF ↗ |
| K954432 | CRYSTAL & CRYSTAL-PLUS IMPLANTS SYSTEM | Crystal Medical Technology | 1996-07-24 | Traditional | PDF ↗ |
| K962130 | BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE | Nobelpharma USA, Inc. | 1996-07-22 | Traditional | PDF ↗ |
| K961737 | CERA ONE ABUTMENT SYSTEM | Nobelpharma USA, Inc. | 1996-07-10 | Traditional | PDF ↗ |
| K933705 | LAMINOSS DENTAL IMPLANT | Impladent , Ltd. | 1996-06-24 | Traditional | PDF ↗ |
| K960634 | TITANIUM HEALING CAPS | The Straumann Co. | 1996-06-18 | Traditional | PDF ↗ |
| K960899 | IMCOR 5.00 MM HEX SELF-TAPPING SCREW W/COVER SCREW | Imcor | 1996-06-17 | Traditional | PDF ↗ |
| K954513 | ACE SREW DENTLA IMPLANT SYSTEM | Ace Surgical Supply Co., Inc. | 1996-06-05 | Traditional | PDF ↗ |
| K961020 | STERI-OSS 6MM DIAMETER TPS COATED IMPLANTS | Steri-Oss, Inc. | 1996-06-05 | Traditional | PDF ↗ |
| K954605 | ACE CYLINDER DENTAL IMPLANT | Ace Surgical Supply Co., Inc. | 1996-06-05 | Traditional | PDF ↗ |
| K960900 | IMCOR 3.75 MM WIDE HEX SELF-TAPPING SCREW W/COVER SCREW | Imcor | 1996-06-05 | Traditional | PDF ↗ |
| K960022 | OPTI-MAX BODY DIAMETER W/5MM TOP W/EXTERNAL HEX, EXTERNALLY THREADED DENTAL IMPLANT COARSE THREADS | Opti-Max | 1996-05-24 | Traditional | PDF ↗ |
| K960979 | SCREW EXTRACTION DEVICE AND THREAD CLEANING TAP | Steri-Oss, Inc. | 1996-05-20 | Traditional | PDF ↗ |
| K960639 | ABUTMENT SELECTION KIT | Nobelpharma USA, Inc. | 1996-05-14 | Traditional | PDF ↗ |
| K961005 | SARGON IMMEDIATE LOAD IMPLANT | Graham & James | 1996-05-06 | Traditional | PDF ↗ |
| K955332 | OPTI-MAX EXTERNALLY THREADED CYLINDRICAL INTERNAL BORE DENTAL IMPLANT, WITH HEALING SCREW | Opti-Max | 1996-05-06 | Traditional | PDF ↗ |
| K954347 | 3I STANDARD THREADED IMPLANT | Implant Innovations, Inc. | 1996-04-01 | Traditional | PDF ↗ |
| K960026 | BIOHORIZONS DENTAL IMPLANT SYSTEM | BioHorizons Implant Systems, Inc. | 1996-03-28 | Traditional | PDF ↗ |
| K960288 | HA & TPS RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM | Lifecore Biomedical, Inc. | 1996-03-28 | Traditional | PDF ↗ |
| K960111 | KIS MT4 | The Implant Center of the Palm Beaches | 1996-03-27 | Traditional | PDF ↗ |
| K960110 | KIS MT3 | The Implant Center of the Palm Beaches | 1996-03-20 | Traditional | PDF ↗ |
| K955281 | ENDOSSEOUS DENTAL IMPLANT & ACCESSORIES | The Straumann Co. | 1996-03-15 | Traditional | PDF ↗ |
| K945848 | FRIALIT(R)-2 DENTAL IMPLANT | Friatec Medical Inc., USA | 1996-03-15 | Traditional | PDF ↗ |
| K945849 | FRIALIT(R)-2 STEPPED CYLINDER WITH FRIOS(R) TI-COATING | Friatec Medical Inc., USA | 1996-03-15 | Traditional | PDF ↗ |
| K960112 | KIS MT5 | The Implant Center of the Palm Beaches | 1996-03-15 | Traditional | PDF ↗ |
| K945847 | FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE | Friatec Medical Inc., USA | 1996-03-15 | Traditional | PDF ↗ |
| K955619 | 5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS | Calcitek, Inc. | 1996-03-08 | Traditional | PDF ↗ |
| K960371 | INTERPORE THREADED IMPLANT | Interpore Intl. | 1996-03-08 | Traditional | PDF ↗ |
| K931647 | PHOENIX 4.0 MM HA COATED DENTAL IMPLANT | Vancouver Implant Center | 1996-03-05 | Traditional | PDF ↗ |
| K954512 | RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM | Lifecore Biomedical, Inc. | 1996-02-23 | Traditional | PDF ↗ |
| K955427 | 3I TITANIUM PLASMA SPRAYED STANDARD THREADED & SELF-TAPPING IMPLANTS | Implant Innovations, Inc. | 1996-02-09 | Traditional | PDF ↗ |
| K960021 | CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMS | Calcitek, Inc. | 1996-02-08 | Traditional | PDF ↗ |
| K943604 | INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM | Calcitek, Inc. | 1996-02-08 | Traditional | PDF ↗ |
| K955428 | 3I HYDROXYLAPATITE COATED STANDARD THREADED & SELF-TAPPING IMPLANTS | Implant Innovations, Inc. | 1996-02-08 | Traditional | PDF ↗ |
| K955492 | INTERPORE IMZ CYL IMPLANT & CYL HEX IMPLT | Interpore Intl. | 1996-01-30 | Traditional | PDF ↗ |
| K955697 | ABUTMENT RETRIEVAL KIT | Nobelpharma USA, Inc. | 1996-01-30 | Traditional | PDF ↗ |
| K955372 | BALL ATTACHMENT SYSTEM | Nobelpharma USA, Inc. | 1996-01-23 | Traditional | PDF ↗ |
| K954819 | RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEM | Lifecore Biomedical, Inc. | 1996-01-11 | Traditional | PDF ↗ |
| K954865 | RESTORE HA DENTAL IMPLANT SYSTEM | Lifecore Biomedical, Inc. | 1996-01-11 | Traditional | PDF ↗ |
| K955048 | KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM | The Implant Center of the Palm Beaches | 1996-01-11 | Traditional | PDF ↗ |
| K933646 | CAL-FORM DENTAL IMPLANTS | Cal-Form, Inc. | 1996-01-04 | Traditional | PDF ↗ |
| K953101 | PARAGON IMPLANT SYSTEM | Core-Vent Bio-Engineering, Inc. | 1995-12-21 | Traditional | PDF ↗ |
| K953558 | KIS II LG HEX SCREW & CYLINDER IMPLANTS | The Implant Center of the Palm Beaches | 1995-12-19 | Traditional | PDF ↗ |
| K946345 | INTEGRAL VIII BIOINTEGRATED DENTAL IMPLANT SYSTEM | Calcitek, Inc. | 1995-11-15 | Traditional | PDF ↗ |
| K946319 | INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM | Calcitek, Inc. | 1995-11-15 | Traditional | PDF ↗ |
| K953234 | SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-B3 | The Implant Center of the Palm Beaches | 1995-11-08 | Traditional | PDF ↗ |
| K952994 | TP-4 WIDE CYLINDER IMPLANTS | Implant Center of the Palm Beaches | 1995-10-31 | Traditional | PDF ↗ |
| K952998 | TP SCREW IMPLANT 3.75, 4.0-B5 | Implant Center of the Palm Beaches | 1995-10-31 | Traditional | PDF ↗ |
| K952997 | PRE ANGULATED PROSTH: 15 DEG ANGLED, 25,& 25 CONE ANGLED | Implant Center of the Palm Beaches | 1995-10-31 | Traditional | PDF ↗ |
| K953000 | WIDE SYSTEM SCREW B5 UNCOATED 5MM, 6MM | Implant Center of the Palm Beaches | 1995-10-31 | Traditional | PDF ↗ |
| K952985 | WIDE SCREWS TP-5B. PROS G5, TOOLS G5 OR 17-4 SS | Implant Center of the Palm Beaches | 1995-10-31 | Traditional | PDF ↗ |
| K952999 | UNCOATED SCREW IMPLANT 3.75, 4.0-B5 | Implant Center of the Palm Beaches | 1995-10-31 | Traditional | PDF ↗ |
| K952996 | HA/TP COATED CYLINDER IMPLANT 3.3,4.0 | Implant Center of the Palm Beaches | 1995-10-31 | Traditional | PDF ↗ |
| K952992 | PROSTHETICS 4MM | Implant Center of the Palm Beaches | 1995-10-31 | Traditional | PDF ↗ |
| K953001 | TP-4K SCREW IMPLANT 3.3, 3.75, 4.0 | Implant Center of the Palm Beaches | 1995-10-31 | Traditional | PDF ↗ |
| K952991 | WIDE SCREW HA-5B, CYL-HA-5 | Implant Center of the Palm Beaches | 1995-10-31 | Traditional | PDF ↗ |
| K954539 | LG HEX PROSTHETICS | The Implant Center of the Palm Beaches | 1995-10-30 | Traditional | PDF ↗ |
| K952917 | STERI-OSS IMMEDIATE PLACEMENT IMPLANT | Steri-Oss, Inc. | 1995-10-16 | Traditional | PDF ↗ |
| K953158 | HAWN UNIVERSAL | Metal-Tech | 1995-10-05 | Traditional | PDF ↗ |
| K946311 | INTEGRAL VII 3.25MM BIOINTEGRATED DENTAL IMPLANT SYSTEM | Calcitek, Inc. | 1995-10-04 | Traditional | PDF ↗ |
| K953435 | BRANEMARK RADIOGRAPHIC DEPTH GUAGE | Nobelpharma USA, Inc. | 1995-10-03 | Traditional | PDF ↗ |
| K950204 | 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS, MINIPLANTS (TM) | Implant Innovations, Inc. | 1995-09-27 | Traditional | PDF ↗ |
| K953774 | BRANEMARK RESTORATIVE INSTRUMENT & COMPONENT TRAY | Nobelpharma USA, Inc. | 1995-09-27 | Traditional | PDF ↗ |
| K926371 | ANGLED 3.25 MM DENTAL IMPLANT ATTACHMENTS | International Implant Seminars | 1995-09-27 | Traditional | PDF ↗ |
| K944225 | DUAL INTEGRATOR DENTAL IMPLANT | Implant Integration Systems, Inc. | 1995-09-27 | Traditional | PDF ↗ |
| K926309 | PHOENIX 4.0 MM DENTAL IMPLANT | Vancouver Implant Center | 1995-09-21 | Traditional | PDF ↗ |
| K953836 | ABUTMENT | Steri-Oss, Inc. | 1995-09-21 | Traditional | PDF ↗ |
| K953775 | BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE) | Nobelpharma USA, Inc. | 1995-09-21 | Traditional | PDF ↗ |
| K926311 | PHOENIX 4.0 MM ANGLED DENTAL ATTACHMENTS | Vancouver Implant Center | 1995-09-21 | Traditional | PDF ↗ |
| K926370 | STRAIGHT 3.25 MM DENTAL IMPLANT ATTACHMENTS | International Implant Seminars | 1995-09-21 | Traditional | PDF ↗ |
| K943180 | INTEGRAL IV BIOINTEGRATED DENTAL IMPLANT SYSTEM | Calcitek, Inc. | 1995-09-21 | Traditional | PDF ↗ |
| K952592 | OPTI-MAX INTERNAL-HEX ANGLED IMPLANT CROWN POST, 10 DEGREE & 20 DEGREE INCLINATIONS | Opti-Max | 1995-09-21 | Traditional | PDF ↗ |
| K926366 | PHOENIX 3.25 MM C.P. COATED DENTAL IMPLANT | International Implant Seminars | 1995-09-21 | Traditional | PDF ↗ |
| K926367 | PHOENIX 3.25 MM HA COATED DENTAL IMPLANT | International Implant Seminars | 1995-09-21 | Traditional | PDF ↗ |
Product code DZE · Class II · Dental. Data: openFDA.