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 6 of 16
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K122300 | T3 DENTAL IMPLANT | Biomet 3i | 2013-01-30 | Traditional | PDF ↗ |
| K121098 | HERO I DENTAL IMPLANT SYSTEM | Kj Meditech Co., Ltd. | 2013-01-17 | Traditional | PDF ↗ |
| K121585 | TS IMPLANT SYSTEM | Osstem Implant Co., Ltd. | 2013-01-07 | Traditional | PDF ↗ |
| K120793 | Z-LOOK3 EVO SLM | Z-Systems AG | 2012-12-21 | Traditional | PDF ↗ |
| K111189 | SYNTEC DENTAL IMPLANT | Syntec Scientific Corp. | 2012-12-20 | Traditional | PDF ↗ |
| K113779 | CONELOG IMPLANT SYSTEM | Altatec GmbH | 2012-12-14 | Traditional | PDF ↗ |
| K122855 | TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS | Straumann USA | 2012-12-12 | Traditional | PDF ↗ |
| K121995 | TS FIXTURE SYSTEM | Osstem Implant Co., Ltd. | 2012-11-29 | Traditional | PDF ↗ |
| K122052 | MINIFIX BALL MINIFIX ONE | Bonafix Surgical and Dental Implants, LLC | 2012-11-28 | Traditional | PDF ↗ |
| K113113 | ENDOSSEOUS DENTAL IMPLANT | Ot Medical GmbH | 2012-11-16 | Traditional | PDF ↗ |
| K122171 | MS SA IMPLANT SYSTEM | Osstem Implant Co., Ltd. | 2012-11-16 | Traditional | PDF ↗ |
| K121047 | HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM | Kj Meditech Co., Ltd. | 2012-10-04 | Traditional | PDF ↗ |
| K122231 | XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM | Megagen Implant Co., Ltd. | 2012-10-04 | Special | PDF ↗ |
| K121707 | LEW MDI O-BALL COLLARED IMPLANT, | Park Dental Research Corp. | 2012-09-24 | Traditional | PDF ↗ |
| K120875 | B&W DENTAL IMPLANT SYSTEM | B&W Srl | 2012-09-07 | Traditional | PDF ↗ |
| K121787 | BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS | BioHorizons Implant Systems, Inc. | 2012-09-05 | Special | PDF ↗ |
| K120792 | TIXOS IMPLANT SYSTEM | Leader Italia S.R.L. | 2012-09-05 | Traditional | PDF ↗ |
| K113376 | NEOSS PROACTIVE TAPERED IMPLANT | Neoss, Ltd. | 2012-09-05 | Traditional | PDF ↗ |
| K113753 | ZIMMER DENTAL TAPERED SCREW-VENT X | Zimmer Dental, Inc. | 2012-08-30 | Traditional | PDF ↗ |
| K120847 | ET/SS IMPLANT SYSTEM | Osstem Implant Co., Ltd. | 2012-08-10 | Special | PDF ↗ |
| K112162 | CONICAL CONNECTION IMPLANTS | Mis Implants Technologies , Ltd. | 2012-08-08 | Traditional | PDF ↗ |
| K112532 | ET II BIO-SA FIXTURE SYSTEM | Hiossen, Inc. | 2012-08-06 | Traditional | PDF ↗ |
| K120414 | OSSEOSPEED PLUS | Astra Tech AB | 2012-07-31 | Traditional | PDF ↗ |
| K110425 | HC-BIOS DENTAL IMPLANT | Hung Chun Bio-S Co., Ltd. | 2012-07-27 | Traditional | PDF ↗ |
| K120530 | DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S | Dentin Implants Technologies , Ltd. | 2012-07-05 | Traditional | PDF ↗ |
| K103577 | TRINON Q & Q3 IMPLANT SYSTEM | Trinon Titanium GmbH | 2012-07-03 | Traditional | PDF ↗ |
| K120503 | CMI IMPLANT IS II ACTIVE | Neobiotech Co., Ltd. | 2012-06-18 | Traditional | PDF ↗ |
| K121131 | BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM | Straumann USA | 2012-06-06 | Traditional | PDF ↗ |
| K120198 | LOCATOR OVERDENTURE IMPLANT SYSTEM | Zest Anchors, LLC | 2012-06-06 | Traditional | PDF ↗ |
| K111798 | STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ... | Sterngold Dental, LLC | 2012-06-01 | Abbreviated | PDF ↗ |
| K112585 | TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM | Adin Dental Implants System, Ltd. | 2012-05-24 | Special | PDF ↗ |
| K112279 | QUANTUM DENTAL IMPLANT SYSTEM | Quantum Bioengineering, Ltd. | 2012-05-04 | Traditional | PDF ↗ |
| K120043 | CSM INTERNAL-R IMPLANT SYSTEM | Csm Implant | 2012-04-27 | Traditional | PDF ↗ |
| K112795 | PALTOP DENTAL IMPLANT SYSTEM | Paltop Advanced Dental Solutions, Ltd. | 2012-04-20 | Traditional | PDF ↗ |
| K112440 | AB DENTAL DEVICES IMPLANTS AND ACCESSORIES | A.B. Dental Devices , Ltd. | 2012-04-18 | Traditional | PDF ↗ |
| K113554 | CMI IMPLANT IS SYSTEM | Neobiotech Co., Ltd. | 2012-04-05 | Special | PDF ↗ |
| K110337 | UNIVERSAL MAXILLARY MOLAR | Oco Biomedical | 2012-03-16 | Traditional | PDF ↗ |
| K112758 | KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10 | Kat Implants, LLC | 2012-02-23 | Traditional | PDF ↗ |
| K112540 | S-MINI IMPLANT SYSTEM | Neobiotech Co., Ltd. | 2012-02-03 | Traditional | PDF ↗ |
| K111364 | HAPTITE COATING IMPLANT SYSTEM | Dentis Co., Ltd. | 2012-02-01 | Traditional | PDF ↗ |
| K112875 | BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS | Blue Sky Bio, LLC | 2012-01-27 | Traditional | PDF ↗ |
| K111162 | SLIM ONEBODY SYSTEM | Dentium Co., Ltd. | 2012-01-13 | Abbreviated | PDF ↗ |
| K112160 | TAPERED SCREW-VENT X IMPLANT | Zimmer Dental, Inc. | 2011-12-14 | Traditional | PDF ↗ |
| K111889 | ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT | Zimmer Dental, Inc. | 2011-12-06 | Traditional | PDF ↗ |
| K110955 | ANYRIDGE INTERNAL IMPLANT SYSTEM | Megagen Co., Ltd. | 2011-11-22 | Traditional | PDF ↗ |
| K111216 | OSSEOTITE 2 DENTAL IMPLANTS | Biomet 3i, Inc. | 2011-11-18 | Special | PDF ↗ |
| K112746 | DIOSLIMON IMPLANT SYSTEM | Dio Corporation | 2011-10-21 | Special | PDF ↗ |
| K111120 | CSM SUBMERGED-R IMPLANT SYSTEM | Csm Implant | 2011-10-14 | Traditional | PDF ↗ |
| K111357 | STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM | Straumann USA | 2011-10-03 | Traditional | PDF ↗ |
| K111287 | ASTRA TECH IMPLANT SYSTEM | Astra Tech AB | 2011-09-26 | Traditional | PDF ↗ |
| K103089 | SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS | Mis - Implant Technologies , Ltd. | 2011-09-15 | Traditional | PDF ↗ |
| K111003 | BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL | Biodenta Swiss AG | 2011-09-15 | Traditional | PDF ↗ |
| K103810 | KJ SUBMERGED SYSTEM | Kj Meditech Co., Ltd. | 2011-09-14 | Traditional | PDF ↗ |
| K103790 | ACE TRIMARK TRICAM DENTAL IMPLANT | Ace Surgical Supply Company, Inc. | 2011-08-18 | Traditional | PDF ↗ |
| K110548 | OSI O-BALL ABUTMENT HEAD IMPLANTS | Juell Dental | 2011-07-29 | Traditional | PDF ↗ |
| K110577 | OSSEOFUSE DENTAL IMPLANT SYSTEM | Dynamic Innovations, Inc. | 2011-07-14 | Traditional | PDF ↗ |
| K103194 | INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM | Intra-Lock International, Inc. | 2011-04-21 | Abbreviated | PDF ↗ |
| K102034 | BLUE SKY BIO DENTAL IMPLANT SYSTEM | Blue Sky Bio, LLC | 2011-04-19 | Traditional | PDF ↗ |
| K101201 | STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064, | Kat Implants, LLC | 2011-04-13 | Traditional | PDF ↗ |
| K100724 | OSSEOTITE II MODEL XIFOSSXXX | Biomet 3i, Inc. | 2011-04-01 | Traditional | PDF ↗ |
| K102635 | APOLONIA LASER IMPLANT SYSTEM | Csm Implant Co., Ltd. | 2011-03-22 | Traditional | PDF ↗ |
| K101913 | ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM | Anthogyr Sas | 2011-03-11 | Abbreviated | PDF ↗ |
| K103537 | ET III SA ULTRA WIDE SYSTEM | Hiossen, Inc. | 2011-03-10 | Special | PDF ↗ |
| K101732 | ASTRA TECH IMPLANT SYSTEM | Astra Tech AB | 2011-02-23 | Traditional | PDF ↗ |
| K101945 | NEODENT IMPLANT SYSTEM | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011-01-26 | Traditional | PDF ↗ |
| K101225 | PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1 | Promimic AB | 2011-01-25 | Traditional | PDF ↗ |
| K102822 | IMPLANT-ONE SYSTEM | Custom Dental Implants, Inc. | 2011-01-10 | Traditional | PDF ↗ |
| K093595 | CERAROOT IMPLANT SYSTEM | Oral Iceberg S.L. | 2011-01-04 | Traditional | PDF ↗ |
| K100932 | INCLUSIVE MINI IMPLANT | Prismatik Dentalcraft, Inc. | 2010-12-27 | Abbreviated | PDF ↗ |
| K102981 | ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM | Ace Surgical Supply Company, Inc. | 2010-12-20 | Special | PDF ↗ |
| K100850 | COWELL IMPLANT SYSTEM | Cowellmedi Co., Ltd. | 2010-12-20 | Traditional | PDF ↗ |
| K102436 | NOBEL ACTIVE 3.0 | Nobel Biocare AB | 2010-12-09 | Traditional | PDF ↗ |
| K093749 | GC AADVA IMPLANT SYSTEM | GC America, Inc. | 2010-12-06 | Abbreviated | PDF ↗ |
| K101755 | AIDI DENTAL IMPLANT SYSTEM | Aidi Biomedical, LLC | 2010-11-22 | Traditional | PDF ↗ |
| K102308 | SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS | Dentium Co., Ltd. | 2010-11-22 | Special | PDF ↗ |
| K100100 | DIO STEADY EXTERNAL IMPLANT SYSTEM | Dio Corporation | 2010-11-10 | Traditional | PDF ↗ |
| K101545 | GENESIS IMPLANT SYSTEM | Keystone Dental | 2010-10-28 | Abbreviated | PDF ↗ |
| K093562 | ENDOSSEOUS DENTAL IMPLANT | Southern Implants, Inc. | 2010-10-14 | Traditional | PDF ↗ |
| K101096 | HT III SA FIXTURE SYSTEM | Hiossen, Inc. | 2010-10-08 | Traditional | PDF ↗ |
| K101849 | BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT | Bicon, LLC | 2010-10-01 | Traditional | PDF ↗ |
| K101880 | TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT | Zimmer Dental, Inc. | 2010-10-01 | Traditional | PDF ↗ |
| K101977 | TAPERED SCREW-VENT T IMPLANT | Zimmer Dental, Inc. | 2010-09-14 | Traditional | PDF ↗ |
| K082800 | STAR/VENT INTERNAL HEX SCREW IMPLANT | Park Dental Research Corp. | 2010-08-26 | Traditional | PDF ↗ |
| K101207 | NEODENT IMPLANT SYSTEM | Jjgc Industria E Comercio DE Materiais Dentarios S | 2010-08-02 | Traditional | PDF ↗ |
| K100411 | VARIOUS DENTAL IMPLANTS | Grundy Advanced Biomedical Systems, LLC | 2010-07-28 | Traditional | PDF ↗ |
| K092261 | DEFCON TSA/TSH DENTAL IMPLANT SYSTEM | Impladent, S.L. | 2010-07-23 | Abbreviated | PDF ↗ |
| K082573 | SARGON NON-EXPANDABLE DENTAL IMPLANT | Sargon Ent., Inc. | 2010-07-21 | Traditional | PDF ↗ |
| K100511 | COTEC DENTAL IMPLANT SYSTEM | Cotec Implant Co., Ltd. | 2010-07-09 | Traditional | PDF ↗ |
| K100902 | AEDIS(TM) | Embed Technology, LLC | 2010-06-24 | Abbreviated | PDF ↗ |
| K093630 | BIODENTA DENTAL IMPLANT SYSTEM | Biodenta Swiss AG | 2010-06-03 | Traditional | PDF ↗ |
| K092507 | ZIT-Z | Ziterion | 2010-05-11 | Traditional | PDF ↗ |
| K092542 | M | Mediscitec, Inc. | 2010-04-23 | Traditional | PDF ↗ |
| K093889 | MODIFICATION TO: HG III ULTRA WIDE SYSTEM | Hiossen, Inc. | 2010-04-22 | Special | PDF ↗ |
| K093321 | BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM | BioHorizons Implant Systems, Inc. | 2010-04-02 | Traditional | PDF ↗ |
| K093615 | SPI DENTAL IMPLANT, ELEMENT | Thommen Medical AG | 2010-03-04 | Traditional | PDF ↗ |
| K091208 | GS III SYSTEM | Osstem Implant Co., Ltd. | 2010-03-03 | Traditional | PDF ↗ |
| K091678 | HG II SHORT FIXTURE SYSTEM | Osstem Implant Co., Ltd. | 2010-02-18 | Traditional | PDF ↗ |
| K093027 | STRAUMANN RC TEMPORARY ABUTMENTS | Straumann USA | 2010-02-12 | Special | PDF ↗ |
| K091387 | BTI DENTAL IMPLANT 5.5-6.5 | B.T.I. Biotechnology Institute, Sl. | 2010-01-22 | Traditional | PDF ↗ |
| K093518 | ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM | Ace Surgical Supply Co., Inc. | 2010-01-14 | Special | PDF ↗ |
Product code DZE · Class II · Dental. Data: openFDA.