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 7 of 16
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K091182 | CHAMPIONS IMPLANTS GMBH MIMI 1-PIECE PRECISION IMPLANT, MODEL 1000 UP TO 6000 | Champions Implants GmbH | 2010-01-07 | Traditional | PDF ↗ |
| K092555 | UNO NARROW IMPLANT | Mis Implants Technologies , Ltd. | 2010-01-05 | Traditional | PDF ↗ |
| K092674 | SIMPLER TOADSTOOL MINI IMPLANT | Pan Global Implant | 2009-12-28 | Traditional | PDF ↗ |
| K093164 | 3.25 SPLINE TWIST IMPLANT, HA COATED | Zimmer Dental, Inc. | 2009-12-15 | Traditional | PDF ↗ |
| K091051 | BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM | Tita-Link | 2009-12-08 | Traditional | PDF ↗ |
| K093352 | HG III FIXTURE SYSTEM | Hiossen, Inc. | 2009-11-24 | Special | PDF ↗ |
| K092434 | STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM | Sterngold | 2009-11-10 | Abbreviated | PDF ↗ |
| K092035 | BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION | Bicon, LLC | 2009-10-15 | Traditional | PDF ↗ |
| K092112 | BTI DENTAL IMPLANT TINY 2.5-3.0 | B.T.I. Biotechnology Institute, Sl. | 2009-10-06 | Traditional | PDF ↗ |
| K091878 | OSSEOLINK DENTAL IMPLANT SYSTEM | Global Implant Solutions, LLC | 2009-10-06 | Traditional | PDF ↗ |
| K090716 | BEGO SEMADOS S-LINE | Bego Implant Systems GmbH & Co. KG | 2009-10-06 | Traditional | PDF ↗ |
| K091239 | ASTRA TECH IMPLANT SYSTEM | Astra Tech AB | 2009-09-22 | Traditional | PDF ↗ |
| K092594 | ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OX | Ace Surgical Supply Co., Inc. | 2009-09-16 | Special | PDF ↗ |
| K090174 | TSI; ERI | Oco Biomedical | 2009-09-14 | Traditional | PDF ↗ |
| K090377 | SINUS QUICK EB SYSTEM | Neobiotech Co., Ltd. | 2009-08-28 | Traditional | PDF ↗ |
| K090054 | ATLAS IMPLANT SYSTEM - WIDE PLUS | Cowellmedi Co., Ltd. | 2009-07-29 | Traditional | PDF ↗ |
| K090154 | SPI DENTAL IMPLANT INICELL | Thommen Medical AG | 2009-07-27 | Traditional | PDF ↗ |
| K083670 | UNIVERSAL, AESTHETICA, NATEA, NATURA | Euroteknika | 2009-07-23 | Traditional | PDF ↗ |
| K090825 | SQ IS SYSTEM | Neobiotech Co., Ltd. | 2009-07-16 | Traditional | PDF ↗ |
| K090527 | SINUS QUICK IT SYSTEM | Neobiotech Co., Ltd. | 2009-07-14 | Traditional | PDF ↗ |
| K090709 | CORTEX DENTAL IMPLANT SYSTEM | Cortex Dental Implants Industries , Ltd. | 2009-07-07 | Traditional | PDF ↗ |
| K082843 | MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM | Dentis Co., Ltd. | 2009-06-19 | Traditional | PDF ↗ |
| K083669 | OBI | Euroteknika | 2009-06-08 | Traditional | PDF ↗ |
| K083805 | ANKYLOS C/X DENTAL IMPLANT SYSTEM | Dentsply Intl., Inc. | 2009-05-22 | Traditional | PDF ↗ |
| K090452 | NEOSS IMPLANT SYSTEM 03.25 | Neoss, Ltd. | 2009-05-22 | Traditional | PDF ↗ |
| K090005 | BRANEMARK INTEGRATION BIOHELIX IMPLANTS | Branemark Integration AB | 2009-05-19 | Special | PDF ↗ |
| K090234 | SPECTRA SYSTEM DENTAL IMPLANTS 2008 | Implant Direct, LLC | 2009-05-15 | Traditional | PDF ↗ |
| K083633 | HS II SHORT FIXTURE SYSTEM | Osstem Implant Co., Ltd. | 2009-05-01 | Traditional | PDF ↗ |
| K083586 | I-FIX SYSTEM | Dentis Co., Ltd. | 2009-04-29 | Traditional | PDF ↗ |
| K090049 | ATLAS IMPLANT SYSTEM- MINI PLUS | Cowellmedi Co., Ltd. | 2009-04-20 | Traditional | PDF ↗ |
| K090237 | HG II FIXTURE SYSTEM | Hiossen, Inc. | 2009-04-17 | Traditional | PDF ↗ |
| K083869 | BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISI | Btlock Srl | 2009-03-27 | Abbreviated | PDF ↗ |
| K081748 | ONEPLANT DENTAL IMPLANT SYSTEM | Warantec Co., Ltd. | 2009-03-27 | Traditional | PDF ↗ |
| K083886 | SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004 | Simpler One Stop | 2009-03-23 | Traditional | PDF ↗ |
| K083543 | DENOVISMED DENTAL IMPLANT SYSTEMS | Denovis Medical, LLC | 2009-03-06 | Traditional | PDF ↗ |
| K083550 | STRAUMANN DENTAL IMPLANT SYSTEM | Straumann USA | 2009-02-26 | Traditional | PDF ↗ |
| K090260 | MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS | Straumann Manufacturing, Inc. | 2009-02-26 | Special | PDF ↗ |
| K081419 | STRAUMANN DENTAL IMPLANT SYSTEM | Institut Straumann AG | 2009-02-20 | Traditional | PDF ↗ |
| K083205 | NOBELACTIVE 8.5 MM & 18.0 MM | Nobel Biocare AB | 2009-02-13 | Traditional | PDF ↗ |
| K083561 | NEOSS PROACTIVE IMPLANT | Neoss, Ltd. | 2009-02-11 | Special | PDF ↗ |
| K083067 | MS SYSTEM | Osstem Implant Co., Ltd. | 2009-02-02 | Traditional | PDF ↗ |
| K083496 | CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS | Altatec GmbH | 2009-01-30 | Traditional | PDF ↗ |
| K083297 | PITT-EASY DENTAL IMPLANT SYSTEM | Sybron Implant Solutions GmbH | 2009-01-28 | Traditional | PDF ↗ |
| K082651 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Southern Implants, Inc. | 2008-12-22 | Traditional | PDF ↗ |
| K082639 | ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS | Zimmer Dental, Inc. | 2008-12-19 | Traditional | PDF ↗ |
| K081751 | ADIN DENTAL IMPLANTS SYSTEM | Adin Dental Implants System, Ltd. | 2008-12-19 | Traditional | PDF ↗ |
| K082749 | OMNI-TIGHT | Basic Dental Implant Systems, Inc. | 2008-12-04 | Special | PDF ↗ |
| K082838 | ORLUS MINI SCREW | Ortholution Co., Ltd. | 2008-11-25 | Special | PDF ↗ |
| K082200 | KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5 | SOADCO, S.L. | 2008-11-25 | Traditional | PDF ↗ |
| K081818 | BIOLOK MICRO-LOK IMPLANT SYSTEM | BioHorizons Implant Systems, Inc. | 2008-11-13 | Special | PDF ↗ |
| K081128 | MOLAR IMPLANT | Nobel Biocare AB | 2008-11-07 | Traditional | PDF ↗ |
| K081806 | IDI IMPLANT SYSTEM | Idi Biomedical, LLC | 2008-11-07 | Traditional | PDF ↗ |
| K081900 | TEMPORARY TOOTH REPLACEMENT | Ormco Corp. | 2008-10-24 | Traditional | PDF ↗ |
| K073645 | SIMPLER MINI DENTAL IMPLANT: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004 2.5 X 15MM | 659543 BC , Ltd. | 2008-10-21 | Traditional | PDF ↗ |
| K082213 | GS III FIXTURE SYSTEM | Osstem Implant Co., Ltd. | 2008-10-14 | Special | PDF ↗ |
| K073368 | 5.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT | Bicon, LLC | 2008-10-10 | Traditional | PDF ↗ |
| K080559 | DIO SM IMPLANT SYSTEM | Dsi, Inc. | 2008-10-09 | Traditional | PDF ↗ |
| K081653 | MDI MII ONE-PIECE IMPLANT, 2.9MM | Imtec Corp. | 2008-09-19 | Traditional | PDF ↗ |
| K081579 | INVENTUS IMPLANT SYSTEM | Inventus Co., Ltd. | 2008-09-17 | Traditional | PDF ↗ |
| K080156 | OSSEOSPEED TM PROFILE SYSTEM | Astra Tech AB | 2008-09-17 | Traditional | PDF ↗ |
| K081226 | SIMPACT IMPLANT SYSTEM | Simpact, LLC | 2008-09-12 | Traditional | PDF ↗ |
| K071803 | ARDS DENTAL IMPLANTS | Ards, Ltd. | 2008-09-05 | Traditional | PDF ↗ |
| K080594 | MS SYSTEM (NARROW RIDGE) | Osstem Implant Co., Ltd. | 2008-09-03 | Traditional | PDF ↗ |
| K081302 | RESCUE EXTERNAL IMPLANT SYSTEM | Megagen Implant Co., Ltd. | 2008-08-15 | Traditional | PDF ↗ |
| K080744 | HG II FIXTURE SYSTEM | Osstem Implant Co., Ltd. | 2008-07-17 | Traditional | PDF ↗ |
| K081078 | NT/IT SYSTEM | Osstem Implant Co., Ltd. | 2008-07-15 | Traditional | PDF ↗ |
| K080633 | SCREWINDIRECT DENTAL IMPLANTS | Implant Direct, LLC | 2008-07-15 | Traditional | PDF ↗ |
| K080224 | KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK | SOADCO, S.L. | 2008-07-03 | Traditional | PDF ↗ |
| K080129 | SECURE IMPLANT SYSTEM (2.5/3.0MM) | Dio Department Dsi, Inc. | 2008-05-30 | Traditional | PDF ↗ |
| K080115 | I-MINI DENTAL IMPLANT | Oco Biomedical | 2008-05-30 | Traditional | PDF ↗ |
| K080713 | REACTIVE DENTAL IMPLANT SYSTEM | Implant Direct, LLC | 2008-05-16 | Traditional | PDF ↗ |
| K073070 | DIO BIOTITE-H IMPLANT SYSTEM | Dio Department Dsi, Inc. | 2008-05-16 | Traditional | PDF ↗ |
| K080128 | SM-EXTRA WIDE (RBM) IMPLANT SYSTEM | Dio Department Dsi, Inc. | 2008-05-14 | Traditional | PDF ↗ |
| K073622 | EASY GRIP DENTAL IMPLANT SYSTEM | T.F.I. System S.R.L | 2008-05-14 | Traditional | PDF ↗ |
| K072595 | OMNI-TIGHT | Basic Dental Implant Systems, Inc. | 2008-05-09 | Special | PDF ↗ |
| K080396 | OSSEOSPEED NARROW | Astra Tech AB | 2008-04-30 | Traditional | PDF ↗ |
| K080162 | UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT | Mis Implants Technologies , Ltd. | 2008-04-22 | Traditional | PDF ↗ |
| K070570 | DIO IMPLANT SYSTEM | Dio Department Dsi, Inc. | 2008-04-15 | Traditional | PDF ↗ |
| K080126 | DIO PROTEM IMPLANT SYSTEM | Dio Department Dsi, Inc. | 2008-04-11 | Traditional | PDF ↗ |
| K073058 | RESCUE INTERNAL IMPLANT SYSTEM | Megagen Co., Ltd. | 2008-04-11 | Traditional | PDF ↗ |
| K073465 | US/GS ULTRA WIDE SYSTEM | Osstem Implant Co., Ltd. | 2008-04-07 | Traditional | PDF ↗ |
| K073486 | DENTIS DENTAL IMPLANT SYSTEM | Dentis Co., Ltd. | 2008-04-04 | Traditional | PDF ↗ |
| K073458 | BT-TITE ONE(BTICV1), BT-TITE STANDARD(BTIVSM), BT-TITE CV2(BTICV2) | Btlock Srl | 2008-04-04 | Traditional | PDF ↗ |
| K073075 | FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS | Dentsply International, Inc. | 2008-03-31 | Traditional | PDF ↗ |
| K073713 | BLUE SKY BIO DENTAL IMPLANT SYSTEM | Blue Sky Bio, LLC | 2008-03-28 | Traditional | PDF ↗ |
| K070184 | DENTAL IMPLANT, DENTAL ABUTMENT, ABUTMENT SCREW, COVER SCREW, HEALING ABUTMENT | Ospol AB | 2008-03-24 | Traditional | PDF ↗ |
| K073343 | ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX | Ace Surgical Supply Co., Inc. | 2008-03-13 | Traditional | PDF ↗ |
| K072425 | JNE IMPLANT SYSTEM | GC America, Inc. | 2008-03-10 | Abbreviated | PDF ↗ |
| K073161 | REPLUS DENTAL IMPLANTS (HA) | Implant Direct, LLC | 2008-03-07 | Traditional | PDF ↗ |
| K080387 | HU II / HS II FIXTURE SYSTEM | Osstem Implant Co., Ltd. | 2008-03-07 | Special | PDF ↗ |
| K073247 | US/SS/GS SYSTEM | Osstem Implant Co., Ltd. | 2008-03-07 | Traditional | PDF ↗ |
| K073116 | EBI INTERNAL IMPLANT SYSTEM | Ebi, Inc. | 2008-02-28 | Traditional | PDF ↗ |
| K073282 | BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM | BioHorizons Implant Systems, Inc. | 2008-02-15 | Traditional | PDF ↗ |
| K073067 | ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMS | Dentsply International, Inc. | 2008-02-15 | Traditional | PDF ↗ |
| K072447 | PENTABORN | Mediscitec, Inc. | 2008-02-15 | Traditional | PDF ↗ |
| K080074 | ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX | Ace Surgical Supply Co., Inc. | 2008-02-14 | Special | PDF ↗ |
| K073268 | BIOHORIZONS INTERNAL IMPLANT SYSTEM | BioHorizons Implant Systems, Inc. | 2008-02-08 | Traditional | PDF ↗ |
| K071148 | ATLAS IMPLANT SYSTEM | Cowellmedi Co., Ltd. | 2008-02-06 | Traditional | PDF ↗ |
| K072959 | MS SYSTEM (DENTURE) | Osstem Implant Co., Ltd. | 2008-02-04 | Traditional | PDF ↗ |
| K072363 | NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX | Biomet 3i, Inc. | 2008-01-31 | Traditional | PDF ↗ |
Product code DZE · Class II · Dental. Data: openFDA.