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 8 of 16
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K071240 | IMPLASA-HOECHST GMBH IMPLANTS | Implasa-Hoechst GmbH | 2008-01-24 | Traditional | PDF ↗ |
| K072917 | JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM | Odontit S.A. | 2008-01-14 | Traditional | PDF ↗ |
| K073142 | NOBELREPLACE HEXAGONAL IMPLANT | Nobel Biocare USA, LLC | 2008-01-11 | Special | PDF ↗ |
| K072871 | MS SYSTEM (PROVISIONAL) | Osstem Implant Co., Ltd. | 2008-01-10 | Traditional | PDF ↗ |
| K070857 | NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM | Nobel Biocare AB | 2007-12-28 | Traditional | PDF ↗ |
| K072980 | NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS | Nobel Biocare AB | 2007-12-20 | Special | PDF ↗ |
| K073049 | SCREWPLUS DENTAL IMPLANTS (HA) | Implant Direct, LLC | 2007-12-13 | Traditional | PDF ↗ |
| K072660 | ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 | Imtec Corp. | 2007-12-12 | Traditional | PDF ↗ |
| K073033 | LEGACY DENTAL IMPLANTS | Implant Direct, LLC | 2007-12-10 | Traditional | PDF ↗ |
| K072649 | SPI SYSTEM DENTAL IMPLANTS | Thommen Medical AG | 2007-12-06 | Traditional | PDF ↗ |
| K062931 | IMPLUS IMPLANT SYSTEM | Leader Italia S.R.L. | 2007-11-28 | Traditional | PDF ↗ |
| K071161 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Southern Implants, Inc. | 2007-11-16 | Traditional | PDF ↗ |
| K072933 | SPI CONTACT PLATFORM O 4.0 MM | Thommen Medical AG | 2007-11-15 | Special | PDF ↗ |
| K070935 | T.B.R. ZIRCONNECT | Sudimplant SA | 2007-11-09 | Abbreviated | PDF ↗ |
| K070569 | SM INTERNAL./EXTERNAL IMPLANT SYSTEM | Dio Department Dsi, Inc. | 2007-11-08 | Traditional | PDF ↗ |
| K072896 | GS FIXTURE SYSTEM | Osstem Implant Co., Ltd. | 2007-11-06 | Special | PDF ↗ |
| K062542 | Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX | Z-Systems AG | 2007-10-29 | Traditional | PDF ↗ |
| K071070 | OLYMPUS DENTAL IMPLANT SYSTEM | Keystone Dental, Inc. | 2007-10-23 | Traditional | PDF ↗ |
| K072768 | RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS | Lifecore Biomedical, Inc. | 2007-10-23 | Special | PDF ↗ |
| K071851 | HDC STERILE SPIDER SCREW | Hdc S.R.L. | 2007-10-18 | Traditional | PDF ↗ |
| K070601 | MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM | Intra-Lock International | 2007-10-12 | Traditional | PDF ↗ |
| K071638 | BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM | BioHorizons Implant Systems, Inc. | 2007-10-10 | Traditional | PDF ↗ |
| K072589 | TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16 | Zimmer Dental, Inc. | 2007-10-04 | Special | PDF ↗ |
| K063861 | GS SYSTEM | Osstem Implant Co., Ltd. | 2007-09-21 | Traditional | PDF ↗ |
| K071439 | ZIMMER PATIENT-SPECIFIC ABUTMENT, INTERNAL HEX, TITANIUM | Zimmer Dental, Inc. | 2007-09-20 | Traditional | PDF ↗ |
| K071370 | NOBELACTIVE INTERNAL CONNECTION IMPLANT | Nobel Biocare AB | 2007-08-03 | Traditional | PDF ↗ |
| K070841 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Southern Implants, Inc. | 2007-06-21 | Traditional | PDF ↗ |
| K062636 | OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTS | Implant Innovations, Inc. | 2007-06-01 | Traditional | PDF ↗ |
| K071235 | ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13 | Zimmer Dental, Inc. | 2007-05-30 | Special | PDF ↗ |
| K070568 | DIO PROTEM IMPLANT SYSTEM | Dio Department Dsi, Inc. | 2007-05-25 | Traditional | PDF ↗ |
| K070905 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Southern Implants, Inc. | 2007-05-24 | Traditional | PDF ↗ |
| K061323 | MODIFICATION TO RELIADENT DENTAL IMPLANT SYSTEM | Bioinfera, Inc. | 2007-05-23 | Traditional | PDF ↗ |
| K063341 | 3I OSSEOTITE CERTAIN DENTAL IMPLANTS | Implant Innovations, Inc. | 2007-04-30 | Traditional | PDF ↗ |
| K063779 | OSSEOSPEED 4.0S-6MM, MODEL 24619 | Astra Tech, Inc. | 2007-04-27 | Traditional | PDF ↗ |
| K063286 | OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE | Implant Innovations, Inc. | 2007-04-24 | Traditional | PDF ↗ |
| K070022 | MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF9 | Mis Implants Technologies , Ltd. | 2007-04-20 | Special | PDF ↗ |
| K070483 | LEONE MONOIMPLANT FOR O-RING OVERDENTURE | Leone S.P.A. | 2007-04-19 | Traditional | PDF ↗ |
| K070182 | ZYGOMA IMPLANT (IMMEDIATE FUNCTION) | Nobel Biocare AB | 2007-04-04 | Traditional | PDF ↗ |
| K063216 | RESCUE INTERNAL IMPLANT SYSTEM | Megagen Co., Ltd. | 2007-04-02 | Traditional | PDF ↗ |
| K063874 | DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEM | Blue Sky Bio, LLC | 2007-03-29 | Traditional | PDF ↗ |
| K063364 | ALPHA BIO DENTAL IMPLANT SYSTEM | Alpha-Bio Tec , Ltd. | 2007-03-14 | Traditional | PDF ↗ |
| K061971 | ZIRCONIA IMPLANT | Nobel Biocare AB | 2007-03-06 | Traditional | PDF ↗ |
| K061629 | CERTAIN PREVAIL DENTAL IMPLANT | Implant Innovations, Inc. | 2007-02-23 | Special | PDF ↗ |
| K062432 | NANOTITE DENTAL IMPLANTS | Implant Innovations, Inc. | 2007-02-22 | Traditional | PDF ↗ |
| K063523 | ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10, 11, 13, 16; ZOP37A10, 11, 13, 16; ZOP47S10, 11, 13, 16; ZOP4 | Zimmer Dental, Inc. | 2007-02-16 | Traditional | PDF ↗ |
| K070007 | SPI ELEMENT PLATFORM O 4.0 MM | Thommen Medical AG | 2007-01-10 | Special | PDF ↗ |
| K063718 | SFB AND CFB IMPLANTS - 5.0 PLATFORM | Nobel Biocare AB | 2007-01-05 | Special | PDF ↗ |
| K062936 | NOBELPERFECT CONICAL CONNECTION | Nobel Biocare AB | 2006-12-19 | Traditional | PDF ↗ |
| K062367 | MINISCREWS ANCHORING SYSTEM, M.A.S. | Micerium S.P.A. | 2006-12-08 | Traditional | PDF ↗ |
| K062566 | NOBELREPLACE TAPERED CONICAL CONNECTION | Nobel Biocare USA, LLC | 2006-12-06 | Traditional | PDF ↗ |
| K062044 | THE 5.0 X 6.0MM DENTAL IMPLANT | Bicon, Inc. | 2006-11-21 | Traditional | PDF ↗ |
| K062030 | US SYSTEM | Osstem Implant Co., Ltd. | 2006-11-02 | Abbreviated | PDF ↗ |
| K062051 | SS SYSTEM | Osstem Implant Co., Ltd. | 2006-11-01 | Abbreviated | PDF ↗ |
| K062129 | P.0004 IMPLANTS | Institut Straumann AG | 2006-10-20 | Special | PDF ↗ |
| K062156 | SUPER ORTHODONTIC SCREW | Osstem Implant Co., Ltd. | 2006-10-20 | Traditional | PDF ↗ |
| K061319 | SPECTRA SYSTEM | Implant Direct, LLC | 2006-09-29 | Traditional | PDF ↗ |
| K052968 | MODIFICATION TO: ORLUS MINI SCREW | Ortholution Co., Ltd. | 2006-09-08 | Special | PDF ↗ |
| K061717 | ZIMMER ONE-PIECE IMPLANT, 3.7 MM, ANGLED | Zimmer Dental, Inc. | 2006-09-08 | Traditional | PDF ↗ |
| K061410 | SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT | Zimmer Dental, Inc. | 2006-09-08 | Traditional | PDF ↗ |
| K062281 | ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16 | Zimmer Dental, Inc. | 2006-09-05 | Special | PDF ↗ |
| K061797 | SM IMPLANT SYSTEMS | Dio Department Dsi, Inc. | 2006-09-01 | Traditional | PDF ↗ |
| K060958 | STRAUMANN NARROW NECK IMPLANTS | Straumann USA | 2006-08-24 | Traditional | PDF ↗ |
| K061176 | STRAUMANN DENTAL IMPLANTS | Institut Straumann AG | 2006-08-11 | Special | PDF ↗ |
| K061335 | ENHANCE DENTAL IMPLANT SYSTEM | Coastal Biocare | 2006-08-09 | Traditional | PDF ↗ |
| K061500 | SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS | Sic Invent AG | 2006-08-08 | Abbreviated | PDF ↗ |
| K061003 | SFB & CFB IMPLANTS | Nobel Biocare AB | 2006-06-30 | Traditional | PDF ↗ |
| K061169 | ENDOSSEOUS DENTAL IMPLANT | Northern Implants, LLC | 2006-06-20 | Traditional | PDF ↗ |
| K060500 | SPEEDY ORTHODONTIC SCREW | Dentium Co., Ltd. | 2006-06-16 | Traditional | PDF ↗ |
| K060501 | IMPLANTIUM II | Dentium Co., Ltd. | 2006-06-16 | Abbreviated | PDF ↗ |
| K052254 | MYTIS ARROW XXXX | Brainbase Corporation | 2006-06-01 | Traditional | PDF ↗ |
| K053629 | ANCHOR PLUS/NEO ANCHOR PLUS | Kj Meditech | 2006-05-31 | Traditional | PDF ↗ |
| K060126 | ABSOANCHOR MICROIMPLANT | Dentos, Inc. | 2006-05-16 | Traditional | PDF ↗ |
| K060957 | MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM | Blue Sky Bio, LLC | 2006-05-05 | Special | PDF ↗ |
| K060376 | SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-24 | Simpler Implant, Inc. | 2006-04-25 | Special | PDF ↗ |
| K053353 | RESCUE IMPLANT SYSTEM | Megagen Co., Ltd. | 2006-04-19 | Traditional | PDF ↗ |
| K053354 | INTERMEZZO PLUS FIXTURE | Megagen Co., Ltd. | 2006-04-13 | Traditional | PDF ↗ |
| K051798 | OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEM | Osteomed LP | 2006-04-07 | Traditional | PDF ↗ |
| K053478 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Northern Implants, LLC | 2006-04-05 | Traditional | PDF ↗ |
| K053384 | FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM | Astra Tech, Inc. | 2006-03-24 | Traditional | PDF ↗ |
| K051719 | A.B. DENTAL DEVICES | A.B. Dental Devices , Ltd. | 2006-03-21 | Traditional | PDF ↗ |
| K053355 | BTI INTERNA DENTAL IMPLANT SYSTEM | B.T.I. Biotechnology Institute, Sl. | 2006-03-14 | Special | PDF ↗ |
| K053088 | SLACTIVE IMPLANTS | Institut Straumann AG | 2006-02-27 | Traditional | PDF ↗ |
| K050586 | LEONE IMPLANT SYSTEM | Leone S.P.A. | 2006-02-27 | Abbreviated | PDF ↗ |
| K050956 | TBR IDEA CONIC/CONIC | Sudimplant SA | 2006-02-16 | Abbreviated | PDF ↗ |
| K052654 | KLOCKNER DENTAL IMPLANT, MODEL S3M | SOADCO, S.L. | 2006-01-30 | Traditional | PDF ↗ |
| K052951 | ENDOPORE ANATOMIC ENDOSSEOUS DENTAL IMPLANT SYSTEM | Innova Life Sciences Corp. | 2006-01-27 | Traditional | PDF ↗ |
| K052997 | ZIMMER DENTAL ONE-PIECE IMPLANT | Zimmer Dental, Inc. | 2006-01-23 | Traditional | PDF ↗ |
| K052369 | EXFEEL IMPLANT SYSTEM | Megagen Co., Ltd. | 2006-01-10 | Traditional | PDF ↗ |
| K053242 | PITT-EASY DENTAL IMPLANT SYSTEM | Innova Life Sciences Corp. | 2006-01-06 | Special | PDF ↗ |
| K052471 | HDC SPIDER SCREW | Hdc S.R.L. | 2005-12-23 | Traditional | PDF ↗ |
| K052733 | ALMITECH INC. DENTAL IMPLANT SYSTEM | Almitech, Inc. | 2005-12-22 | Traditional | PDF ↗ |
| K052490 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Northern Implants, LLC | 2005-12-08 | Traditional | PDF ↗ |
| K053152 | BIOHORIZONS SINGLE-STAGE IMPLANT | BioHorizons Implant Systems, Inc. | 2005-12-02 | Special | PDF ↗ |
| K052061 | MODUS IMF SCREWS 2.0 | Medartis, Inc. | 2005-10-21 | Traditional | PDF ↗ |
| K050970 | MILO DENTAL IMPLANT SYSTEM | Intra-Lock International | 2005-10-14 | Traditional | PDF ↗ |
| K051859 | SISTEMA DE IMPLANTE NACIONAL (S.I.N.); DENTAL IMPLANT SYSTEM | Sin Sistema DE Implante Nacional Ltda | 2005-09-23 | Traditional | PDF ↗ |
| K052419 | MAXIMUS 3.0 AND OS IMPLANTS | BioHorizons Implant Systems, Inc. | 2005-09-20 | Special | PDF ↗ |
| K051552 | O.A.S.I. SYSTEM | Lancer Orthodontics, Inc. | 2005-09-19 | Traditional | PDF ↗ |
| K051461 | 3I OSSEOTITE DENTAL IMPLANTS | Implant Innovations, Inc. | 2005-09-15 | Traditional | PDF ↗ |
| K051614 | PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS | Lifecore Biomedical, Inc. | 2005-09-09 | Abbreviated | PDF ↗ |
Product code DZE · Class II · Dental. Data: openFDA.