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 11 of 16
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K992334 | ENDOSSEOUS IMPLANTS AND ABUTMENTS- TIN COATING | Implant Innovations, Inc. | 1999-10-08 | Traditional | PDF ↗ |
| K991947 | 3I CERAMIC ABUTMENT SYSTEM | Implant Innovations, Inc. | 1999-09-29 | Traditional | PDF ↗ |
| K991283 | DYNA TORQ TORQUE WRENCH, TORQUE WRENCH | Micro Motors, Inc. | 1999-08-18 | Traditional | PDF ↗ |
| K983120 | BICORTICAL SCREW | Oraltronics Marketing-Und Vertriebs GmbH | 1999-07-29 | Traditional | PDF ↗ |
| K990342 | SYNOCTA PROSTHETICS | Straumann USA | 1999-07-20 | Traditional | PDF ↗ |
| K990304 | MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM | Astra Tech, Inc. | 1999-07-15 | Traditional | PDF ↗ |
| K991114 | REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM | Lifecore Biomedical, Inc. | 1999-07-14 | Traditional | PDF ↗ |
| K991053 | ASTRA TECH IMPLANTS - DENTAL SYSTEM: NEW FIXTURES (MICROMACRO) | Astra Tech, Inc. | 1999-06-25 | Traditional | PDF ↗ |
| K981141 | SARGON IMMEDIATE LOAD IMPLANT, MODEL D | Sargon Ent., Inc. | 1999-06-23 | Traditional | PDF ↗ |
| K984536 | REMOVABLE CUFF ABUTMENT | Sulzer Calcitek, Inc. | 1999-06-16 | Traditional | PDF ↗ |
| K982925 | LAMINOSS DENTAL IMPLANT | Impladent , Ltd. | 1999-05-18 | Traditional | PDF ↗ |
| K984104 | ITI DENTAL IMPLANT SYSTEM | Straumann USA | 1999-05-13 | Traditional | PDF ↗ |
| K991436 | STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTRUMENTATION | Sterngold | 1999-05-07 | Special | PDF ↗ |
| K990367 | PDQ AND PDQ-TI ABUTMENT | Vident | 1999-04-21 | Traditional | PDF ↗ |
| K990983 | MODIFICATION TO IMTEC SENDAX MDI | Imtec Corp. | 1999-04-13 | Special | PDF ↗ |
| K990277 | O-RING ABUTMENT | BioHorizons Implant Systems, Inc. | 1999-04-09 | Traditional | PDF ↗ |
| K981858 | ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW | Atlantis Components, Inc. | 1999-03-22 | Traditional | PDF ↗ |
| K983742 | ITI DENTAL IMPLANT SYSTEM | Institut Straumann AG | 1999-03-15 | Traditional | PDF ↗ |
| K984287 | PROVISIONAL DENTAL IMPLANT SYSTEM | Nobel Biocare Uas, Inc. | 1999-03-01 | Traditional | PDF ↗ |
| K984198 | WIDE BODY ABUTMENTS | Vident | 1999-02-18 | Traditional | PDF ↗ |
| K982488 | BICON BONE SCREW SYSTEM | Bicon, Inc. | 1999-01-26 | Traditional | PDF ↗ |
| K981997 | POSI-STOP/POSI-TRAC SYSTEM | The Dental Medical Device Co., LLC | 1999-01-12 | Traditional | PDF ↗ |
| K983563 | IMCOR 4.00 & 5.00MM SELF-TAPPING LOCKTITE IMPLANTS, IMCOR 4.00 & 5.00MM SELF-TAPPING HA COASTED LOCKTITE IMPLANTS, AND I | Imcor | 1999-01-11 | Traditional | PDF ↗ |
| K983347 | OSSEOTITE DENTAL IMPLANTS | Implant Innovations, Inc. | 1999-01-06 | Traditional | PDF ↗ |
| K974738 | ASTRA TECH IMPLANT DENTAL SYSTEM | Astra Tech, Inc. | 1998-11-19 | Traditional | PDF ↗ |
| K983786 | STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION | Sterngold/Implamed | 1998-11-13 | Special | PDF ↗ |
| K982576 | FRIALIT-2 AUROBASE MODEL NUMBERS 45-2446, 45-2456, 45-2466, 45-2476 | Friatec AG | 1998-10-22 | Traditional | PDF ↗ |
| K982492 | IMCOR DENTAL IMPLANT SYSTEM ACCESSORIES | Imcor | 1998-10-15 | Traditional | PDF ↗ |
| K982305 | SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT | Sulzer Calcitek, Inc. | 1998-09-22 | Traditional | PDF ↗ |
| K982111 | VARIOUS DENTAL IMPLANTS | Biotech Medical Instruments Corp. | 1998-09-15 | Traditional | PDF ↗ |
| K980630 | FRIALIT-2 CORABASE | Friatec AG | 1998-09-04 | Traditional | PDF ↗ |
| K980083 | 3I ORTHODONTIC ABUTMENT, ORTHOBUTMENT | Implant Innovations, Inc. | 1998-08-17 | Traditional | PDF ↗ |
| K974106 | ICON IMPLANT SYSTEM | Bio Science Technologies, Inc. | 1998-06-01 | Traditional | PDF ↗ |
| K974123 | BRANEMARK SYSTEM DEC 600 DRILLING UNIT | Nobel Biocare Uas, Inc. | 1998-05-26 | Traditional | PDF ↗ |
| K980620 | DENTATUS MTI MODULAR TRANSITIONAL IMPLANTS AND PROSTHETIC SYSTEM | Dentatus USA , Ltd. | 1998-05-15 | Traditional | PDF ↗ |
| K981516 | STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB | Sterngold/Implamed | 1998-05-11 | Special | PDF ↗ |
| K980460 | ONPLANT ORTHODONTIC SYSTEM | Nobel Biocare Uas, Inc. | 1998-05-05 | Traditional | PDF ↗ |
| K980549 | OSSEOTITE DENTAL IMPLANT SYSTEM | Implant Innovations, Inc. | 1998-04-28 | Traditional | PDF ↗ |
| K974828 | BRANEMARK SYSTEM(R) EBON(TM) FIXTURE | Nobel Biocare Uas, Inc. | 1998-03-24 | Traditional | PDF ↗ |
| K974737 | ASTRA TECH IMPLANT DENTAL SYSTEM | Astra Tech, Inc. | 1998-03-24 | Traditional | PDF ↗ |
| K980698 | ASTRA TECH IMPLANTS - DENTAL SYSTEM | Astra Tech, Inc. | 1998-03-19 | Traditional | PDF ↗ |
| K980439 | REPLACE CYLINDRICAL IMPLANTS | Steri-Oss, Inc. | 1998-03-16 | Traditional | PDF ↗ |
| K980442 | CRYSTAL AND CRYSTAL-SEAL IMPLANTS SYSTEM | Crystal Medical Technology | 1998-03-16 | Traditional | PDF ↗ |
| K974628 | FRIALIT-2 PROTECT ABUTMENT | Friatec AG | 1998-03-11 | Traditional | PDF ↗ |
| K980374 | IMPLANT SITE DILATORS | BioHorizons Implant Systems, Inc. | 1998-03-04 | Traditional | PDF ↗ |
| K974856 | 3.25MM SIMPLER THREADED DENTAL IMPLANT | Vancouver Implant Resources, Inc. | 1998-02-27 | Traditional | PDF ↗ |
| K974857 | 4.0MM SIMPLER THREADED DENTAL IMPLANT | Vancouver Implant Resources, Inc. | 1998-02-27 | Traditional | PDF ↗ |
| K974401 | 4.0MM SIMPLER ONE THREADED DENTAL IMPLANT | Vancouver Implant Resources, Inc. | 1998-02-23 | Traditional | PDF ↗ |
| K974280 | ABUTMENT - COMPLETE | The Implant Center of the Palm Beaches | 1998-02-20 | Traditional | PDF ↗ |
| K974404 | 4.0MM SIMPLER ONE PUSHIN DENTAL IMPLANT | Vancouver Implant Resources, Inc. | 1998-02-19 | Traditional | PDF ↗ |
| K974402 | 3.25 MM SIMPLER ONE THREADED DENTAL IMPLANT | Vancouver Implant Resources, Inc. | 1998-02-19 | Traditional | PDF ↗ |
| K974403 | 3.25MM SIMPLER ONE PUSHIN DENTAL IMPLANT | Vancouver Implant Resources, Inc. | 1998-02-19 | Traditional | PDF ↗ |
| K974358 | FRIALIT -2 SCREW | Friatec AG | 1998-02-10 | Traditional | PDF ↗ |
| K974359 | FRIALIT-2 CYLINDER | Friatec AG | 1998-02-10 | Traditional | PDF ↗ |
| K974126 | IMCOR 3.75 AND 5.00MM EXTERNALLY HEXED, SELF TAPPING HA COATED SCREW IMPLANTS WITH COVER SCREW | Imcor | 1998-01-30 | Traditional | PDF ↗ |
| K970572 | DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES PARALLEL PIN, DEPTH GAGE, AND SURGICAL RATCHET | Implant Integration Systems, Inc. | 1998-01-16 | Traditional | PDF ↗ |
| K973926 | O BUTMENT HS IMPLANT | O Co., Inc. | 1998-01-05 | Traditional | PDF ↗ |
| K973433 | STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT | Steri-Oss, Inc. | 1997-12-05 | Traditional | PDF ↗ |
| K973423 | STERI-OSS 3.25 MM REPLACE(HYDROXYAPATITE-COATED)DENTAL IMPLANT | Steri-Oss, Inc. | 1997-12-05 | Traditional | PDF ↗ |
| K973771 | DENTAL/SURGICAL DRILLS, BURS, TAPS | Implant Innovations, Inc. | 1997-12-04 | Traditional | PDF ↗ |
| K973353 | BONDING BASE | Straumann USA | 1997-12-02 | Traditional | PDF ↗ |
| K973402 | STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEM | Steri-Oss, Inc. | 1997-11-26 | Traditional | PDF ↗ |
| K972351 | SENDAX MDI (MINI DENTAL IMPLANT) | Sendax Mdic Management, Inc. | 1997-11-24 | Traditional | PDF ↗ |
| K973521 | VARIABLE PARALLEL PIN | Sulzer Calcitek, Inc. | 1997-11-20 | Traditional | PDF ↗ |
| K954030 | BONE-LOCK | Leibinger GmbH | 1997-11-14 | Traditional | PDF ↗ |
| K972769 | OPTI-MAX ANGLED CROWN POST FOR EXTERNALLY-HEXED IMPLANTS, IN 15 DEGREE AND 25 DEGREE INCLINATIONS. FOR IMPLANTS 3.3MM, 4 | Opti-Max | 1997-11-13 | Traditional | PDF ↗ |
| K973049 | IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM | Imcor | 1997-11-13 | Traditional | PDF ↗ |
| K970499 | BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM | Nobel Biocare Uas, Inc. | 1997-10-16 | Traditional | PDF ↗ |
| K972417 | THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM | Bicon, Inc. | 1997-09-17 | Traditional | PDF ↗ |
| K972313 | THE MAESTRO SYSTEM | BioHorizons Implant Systems, Inc. | 1997-09-16 | Traditional | PDF ↗ |
| K950261 | DEVICE FOR PROVIDING QUICK COUPLING FOR DENTAL PROSTHESES | Dr. Joseph E. Grasso, D.D.S. | 1997-09-09 | Traditional | PDF ↗ |
| K961381 | KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS | The Emerging Technologies Group | 1997-09-09 | Traditional | PDF ↗ |
| K950260 | QUICK COUPLING DEVICE FOR DENTAL PROSTHESES | Dr. Joseph E. Grasso, D.D.S. | 1997-09-09 | Traditional | PDF ↗ |
| K972444 | 3I INNOVATIVE IMPLANTS AND COVER SCREWS | Implant Innovations, Inc. | 1997-08-26 | Traditional | PDF ↗ |
| K965032 | THE PERIOSEAL DENTAL IMPLANT | Perioseal | 1997-08-20 | Traditional | PDF ↗ |
| K954758 | ROOTFORM DENTAL IMPLANT SYSTEM | Swiss Dental Center | 1997-08-18 | Traditional | PDF ↗ |
| K972029 | BICON DENTAL IMPLANTS II PART ABUTMENT SYSTEM | Bicon, Inc. | 1997-08-18 | Traditional | PDF ↗ |
| K963520 | IMZ TWIN PLUS SCREW | Imz, GmbH | 1997-08-12 | Traditional | PDF ↗ |
| K963521 | IMZ TWIN PLUS - CYLINDER | Imz, GmbH | 1997-08-06 | Traditional | PDF ↗ |
| K971578 | ENDOSSEOUS DENTAL IMPLANT | Straumann USA | 1997-06-30 | Traditional | PDF ↗ |
| K970127 | EDOSSEOUS DENTAL IMPLANT | Sulzer Calcitek, Inc. | 1997-06-23 | Traditional | PDF ↗ |
| K970752 | SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM | Sulzer Calcitek, Inc. | 1997-06-23 | Traditional | PDF ↗ |
| K970776 | LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT | Lifecore Biomedical, Inc. | 1997-05-27 | Traditional | PDF ↗ |
| K962753 | KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS) | Biomedical Implant Technology, Inc. | 1997-05-19 | Traditional | PDF ↗ |
| K961631 | ODONT HEX SYSTEM | Odontit S.A. | 1997-05-12 | Traditional | PDF ↗ |
| K971196 | ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM | Innova Corp. | 1997-05-08 | Traditional | PDF ↗ |
| K952905 | MINIMATIC VARIOUS IMPLANT SYSTEMS | Minimatic, Inc. | 1997-04-16 | Traditional | PDF ↗ |
| K963030 | LEIBINGER IMF SCREW | Howmedica Leibinger, Inc. | 1997-04-11 | Traditional | PDF ↗ |
| K964739 | STERI-OSS TIODIZED SCREW | Steri-Oss, Inc. | 1997-03-31 | Traditional | PDF ↗ |
| K965077 | SINGLE TOOT ABUTMENT SYSTEM (STA OR ST ABUTMENT ) FOR SINGLE OOTH CEMENT RETAINED RESTORATIONS | Implant Innovations, Inc. | 1997-03-17 | Traditional | PDF ↗ |
| K964220 | REPLACE TITANIUM IMPLANT SYSTEM | Steri-Oss, Inc. | 1997-03-05 | Traditional | PDF ↗ |
| K964046 | DENTSPLY PRECISION TORQUE SYSTEM | Dentsply Intl. | 1997-03-04 | Traditional | PDF ↗ |
| K963522 | IMZ 2000 INTERLOCK 12/3 - SCREW | Imz, GmbH | 1997-03-03 | Traditional | PDF ↗ |
| K963495 | IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM | Imz, GmbH | 1997-03-03 | Traditional | PDF ↗ |
| K965135 | LIFECORE CONICAL ABUTMENT | Lifecore Biomedical, Inc. | 1997-02-25 | Traditional | PDF ↗ |
| K964768 | THREADLOC DENTAL IMPLANT SYSTEMS | Sulzer Calcitek, Inc. | 1997-02-25 | Traditional | PDF ↗ |
| K963945 | STERI-OSS GOLD ATTACHMENT SYSTEM | Steri-Oss, Inc. | 1997-02-11 | Traditional | PDF ↗ |
| K964944 | ROUND DENTAL BUR | Steri-Oss, Inc. | 1997-02-10 | Traditional | PDF ↗ |
| K962576 | SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM | Calcitek, Inc. | 1997-02-10 | Traditional | PDF ↗ |
| K964330 | BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE) | BioHorizons Implant Systems, Inc. | 1997-01-17 | Traditional | PDF ↗ |
Product code DZE · Class II · Dental. Data: openFDA.