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 5 of 16
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K150021 | Z5m(t) | Z-Systems AG | 2015-07-31 | Traditional | PDF ↗ |
| K142813 | Biogensis Implant System-Kisses | Biogenesis Co., Ltd. | 2015-07-31 | Traditional | PDF ↗ |
| K150344 | Dentis Dental Implant System | Dentis Co., Ltd. | 2015-07-24 | Traditional | PDF ↗ |
| K150938 | Straumann® Dental Implant System ¿ Roxolid® SLA Implants | Straumann USA, LLC | 2015-07-24 | Traditional | PDF ↗ |
| K150968 | TRU Dental Implant System | Sterngold Dental, LLC | 2015-07-24 | Abbreviated | PDF ↗ |
| K150537 | MiNi Internal Implant System | Megagen Implant Co., Ltd. | 2015-07-21 | Traditional | PDF ↗ |
| K141777 | NEODENT IMPLANT SYSTEM | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015-07-20 | Traditional | PDF ↗ |
| K143011 | 2014 InterActive/SwishActive System | Implant Direct Sybron Manufacturing, LLC | 2015-07-16 | Traditional | PDF ↗ |
| K150363 | NOVA Dental Implants System | Nova Implants , Ltd. | 2015-06-29 | Traditional | PDF ↗ |
| K150199 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015-06-15 | Traditional | PDF ↗ |
| K142751 | Chang Gung ComMed Series Dental Implant System | Chang Gung Medical Technology Co., Ltd. | 2015-06-15 | Traditional | PDF ↗ |
| K141188 | MICRODENT GENIUS IMPLANT SYSTEM | Implant Microdent | 2015-06-02 | Traditional | PDF ↗ |
| K143326 | T.A.G. Dental Implant System | T.A.G. Medical Products Corporation, Ltd. | 2015-05-14 | Traditional | PDF ↗ |
| K142260 | NobelActive | Nobel Biocare AB | 2015-05-11 | Traditional | PDF ↗ |
| K150182 | Neodent Implant System- CM Drive Implants | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015-04-23 | Special | PDF ↗ |
| K143353 | Hahn Tapered Implant System | Prismatik Dentalcraft, Inc. | 2015-04-02 | Traditional | PDF ↗ |
| K150060 | J2A Dental Implant System, J2C Dental Implant System | Kj Meditech Co., Ltd. | 2015-04-02 | Special | PDF ↗ |
| K142426 | EBI External Implant System | Ebi, Inc. | 2015-03-27 | Traditional | PDF ↗ |
| K140806 | IBS IMPLANT SYSTEM | Innobiosurg Co., Ltd. | 2015-03-23 | Traditional | PDF ↗ |
| K142174 | BIOMATE DENTAL IMPLANT SYSTEM | Biomate Medical Devices Technology Co., Ltd. | 2015-03-20 | Traditional | PDF ↗ |
| K141159 | KONUS DENTAL IMPLANT SYSTEM | Argon Med. Productions Vertriebs Gesellschaft Mbh | 2015-03-11 | Traditional | PDF ↗ |
| K142242 | PREMIUM, SHELTA Implant Systems | Sweden & Martina S.P.A. | 2015-02-02 | Traditional | PDF ↗ |
| K133733 | WINSIX Implant System | Biosaf IN S.R.L. | 2015-01-28 | Traditional | PDF ↗ |
| K143022 | BioHorizons Tapered Internal Implants | BioHorizons Implant Systems, Inc. | 2015-01-08 | Special | PDF ↗ |
| K142667 | Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm | Sterngold Dental, LLC | 2015-01-07 | Abbreviated | PDF ↗ |
| K140440 | NORIS MEDICAL DENTAL IMPLANTS SYSTEM | Noris Medical , Ltd. | 2014-12-19 | Traditional | PDF ↗ |
| K140091 | XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM | Megagen Implant Co., Ltd. | 2014-12-12 | Traditional | PDF ↗ |
| K140202 | TRAUSIM DENTAL IMPLANT SYSTEM | Jiangsu Trausim Medical Instrument | 2014-12-12 | Traditional | PDF ↗ |
| K133362 | SGS DENTAL IMPLANT | Sgs International, Ltd. | 2014-11-21 | Abbreviated | PDF ↗ |
| K140934 | HIOSSEN IMPLANT SYSTEM | Hiossen, Inc. | 2014-11-12 | Traditional | PDF ↗ |
| K140293 | TOUAREG NP CLOSEFIT DENTAL IMPLANTS SYSTEM | Adin Dental Implants Systems , Ltd. | 2014-10-31 | Traditional | PDF ↗ |
| K140052 | J2I IMPLANT SYSTEM | Kj Meditech Co., Ltd. | 2014-10-30 | Traditional | PDF ↗ |
| K140051 | KJ EXTERNAL IMPLANT SYSTEM | Kj Meditech Co., Ltd. | 2014-10-30 | Traditional | PDF ↗ |
| K142082 | ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT | Zimmer Dental, Inc. | 2014-10-28 | Traditional | PDF ↗ |
| K140728 | MPI - MOLECULAR PRECISION IMPLANT, CPI - CYLINDRICAL PRECISION IMPLANT, OPI - ONE PIECE IMPLANT, DENTAL ABUTMENTS AND PR | Ditron Precision, Ltd. | 2014-10-17 | Traditional | PDF ↗ |
| K133050 | ONE PLUS IMPLANT SYSTEM | Osseofuse, Inc. | 2014-09-19 | Traditional | PDF ↗ |
| K141450 | AXIOM 2.8 | Anthogyr Sas | 2014-09-17 | Abbreviated | PDF ↗ |
| K133592 | NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM | Neodent USA, Inc. | 2014-08-22 | Traditional | PDF ↗ |
| K133706 | ZL MICRODENT NATURAL LOCK IMPLANT SYSTEM | Zl Microdent-Attachment GmbH & Co. KG | 2014-08-21 | Traditional | PDF ↗ |
| K140347 | ANKYLOS C/X IMPLANT SYSTEM | Dentsply Intl., Inc. | 2014-08-20 | Traditional | PDF ↗ |
| K140878 | STRAUMANN BONE LEVEL TAPERED IMPLANT | Straumann USA, LLC | 2014-08-20 | Traditional | PDF ↗ |
| K133255 | ZERAMEX T AND ZERAMEX PLUS DENTAL IMPLANT SYSTEMS | Dentalpoint AG | 2014-08-12 | Traditional | PDF ↗ |
| K133991 | ISY | Altatec GmbH | 2014-08-06 | Traditional | PDF ↗ |
| K132881 | Z5C | Z-Systems AG | 2014-07-03 | Traditional | PDF ↗ |
| K133327 | SATURNO(TM) OVERDENTURE IMPLANT SYSTEM | Zest Anchors, LLC | 2014-06-25 | Traditional | PDF ↗ |
| K130694 | JR IMPLANT SYSTEM | LK Consulting Group USA, Inc. | 2014-06-19 | Traditional | PDF ↗ |
| K133884 | BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM | Biodenta Swiss AG | 2014-06-13 | Traditional | PDF ↗ |
| K122807 | DENTAL IMPLANT SYSTEM | Hager& Meisinger GmbH | 2014-06-13 | Traditional | PDF ↗ |
| K132956 | U FIT DENTAL IMPLANT SYSTEM | T Strong, Inc. | 2014-06-05 | Traditional | PDF ↗ |
| K132585 | ZIBONE CERAMIC DENTAL IMPLANT SYSTEM | Coho Technology Co., Ltd. | 2014-06-04 | Abbreviated | PDF ↗ |
| K131557 | RITTER IMPLANT SYSTEM | Ritter Implants GmbH CO KG | 2014-05-09 | Traditional | PDF ↗ |
| K133731 | NOBELACTIVE WIDE PLATFORM (WP) | Nobel Biocare AB | 2014-05-08 | Traditional | PDF ↗ |
| K132178 | MOSTDI DENTAL IMPLANT SYSTEM | Mostdi Innovations Sdn Bhd | 2014-04-30 | Traditional | PDF ↗ |
| K132144 | KERATOR | LK Consulting Group USA, Inc. | 2014-03-21 | Traditional | PDF ↗ |
| K133613 | INTRA-LOCK DENTAL IMPLANTS | Intra-Lock International, Inc. | 2014-03-20 | Traditional | PDF ↗ |
| K131258 | SATURN DENTAL IMPLANT | Cortex Dental Implants Industries , Ltd. | 2014-03-17 | Traditional | PDF ↗ |
| K133339 | ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED | Zimmer Dental, Inc. | 2014-03-04 | Traditional | PDF ↗ |
| K133510 | NEODENT IMPLANT SYSTEM | Jj Industria E Comercio DE Materiais Dentarios SA | 2014-02-24 | Traditional | PDF ↗ |
| K131066 | AXIOM REG | Anthogyr Sas | 2014-02-21 | Traditional | PDF ↗ |
| K132125 | A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEM | A.B. Dental Devices , Ltd. | 2014-01-21 | Traditional | PDF ↗ |
| K133049 | 3I T3(R) EXTERNAL HEX DENTAL IMPLANTS | Biomet 3i | 2014-01-08 | Traditional | PDF ↗ |
| K130572 | INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM | Implant Direct Sybron Manufacturing, LLC | 2013-12-24 | Traditional | PDF ↗ |
| K132992 | TI STAR IMPLANT SYSTEM | T-Plus Implant Tech. Co., Ltd. | 2013-12-18 | Traditional | PDF ↗ |
| K123861 | AIDI DENTAL IMPLANT SYSTEM | Aidi Biomedical, LLC | 2013-12-12 | Traditional | PDF ↗ |
| K121873 | AVINENT DENTAL IMPLANT SYSTEM | Avinent Implant System S.L. | 2013-12-11 | Abbreviated | PDF ↗ |
| K132242 | INNO SLA SUBMERGED IMPLANT SYSTEM | Cowellmedi Co., Ltd. | 2013-12-06 | Traditional | PDF ↗ |
| K131682 | UD IMPLANT SYSTEM | Medimecca Co., Ltd. | 2013-12-05 | Traditional | PDF ↗ |
| K132258 | ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM | Zimmer Dental, Inc. | 2013-11-19 | Traditional | PDF ↗ |
| K130829 | IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS | Iq Implants , Ltd. | 2013-11-14 | Traditional | PDF ↗ |
| K131165 | ANKER DENTAL IMPLANT SYSTEM | Alliance Global | 2013-11-14 | Traditional | PDF ↗ |
| K131748 | OSSEOFUSE DENTAL IMPLANT SYSTEM | Osseofuse, Inc. | 2013-10-31 | Special | PDF ↗ |
| K123155 | LUNA DENTAL IMPLANT SYSTEM | Shinhung Mst Co., Ltd. | 2013-10-31 | Abbreviated | PDF ↗ |
| K130999 | OSSEOSPEED PROFILE EV | Dentsply Implants Manufacturing GmbH | 2013-10-25 | Traditional | PDF ↗ |
| K131701 | Z5MLB, Z5MLC | Z-Systems AG | 2013-09-05 | Traditional | PDF ↗ |
| K130462 | PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT | Paltop Advanced Dental Solutions, Ltd. | 2013-08-27 | Traditional | PDF ↗ |
| K131097 | LEGACY3 6MM LENGTH IMPLANTS | Implant Direct Sybron Manufacturing, LLC | 2013-08-22 | Traditional | PDF ↗ |
| K131451 | PALTOP DENTAL IMPLANT - STERILE ACCESSORIES | Paltop Advanced Dental Solutions, Ltd. | 2013-08-22 | Special | PDF ↗ |
| K123988 | ANYONETM INTERNAL IMPLANT SYSTEM | Megagen Implant Co., Ltd. | 2013-08-15 | Traditional | PDF ↗ |
| K131345 | TIARRAY DENTAL IMPLANT SYSTEM | Nasseo, Inc. | 2013-08-07 | Traditional | PDF ↗ |
| K130140 | INTRA-LOCK OP DENTAL IMPLANT | Intra-Lock International | 2013-08-01 | Traditional | PDF ↗ |
| K130949 | CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS | Biomet 3i | 2013-07-30 | Traditional | PDF ↗ |
| K123471 | ETII SA FIXTURE SYSTEM | Hiossen, Inc. | 2013-07-05 | Traditional | PDF ↗ |
| K130787 | QUANTUM DENTAL IMPLANT SYSTEM | Quantum Bioengineering, Ltd. | 2013-06-13 | Traditional | PDF ↗ |
| K122519 | DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM | Dio Corporation | 2013-05-21 | Traditional | PDF ↗ |
| K122804 | ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM | Intai Technology Corp. | 2013-05-20 | Traditional | PDF ↗ |
| K123022 | NEODENT IMPLANT SYSTEM | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013-05-17 | Traditional | PDF ↗ |
| K113539 | REVOIS PRO IMPLANT STSYEM | Riemser Arzneimittel AG | 2013-05-03 | Traditional | PDF ↗ |
| K122664 | ZUGA DENTAL IMPLANT SYSTEM | Zuga Medical, Inc. | 2013-04-30 | Traditional | PDF ↗ |
| K130222 | STRAUMANN DENTAL IMPLANT SYSTEM | Straumann USA, LLC | 2013-04-29 | Traditional | PDF ↗ |
| K123386 | PERIOTYPE X-PERT | Clinical House Europe GmbH | 2013-04-26 | Traditional | PDF ↗ |
| K123784 | STRAUMANN DENTAL IMPLANT SYSTEM | Straumann USA, LLC | 2013-04-10 | Traditional | PDF ↗ |
| K121281 | SIMPLI SIMPLER IMPLANT SYSTEM | Simpler Implant Solutions | 2013-04-05 | Abbreviated | PDF ↗ |
| K122198 | 6.00MM X 6.00MM MACRO EXTERNAL IMPLANT SYSTEM | Oco Biomedical | 2013-04-05 | Traditional | PDF ↗ |
| K123512 | BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM | Biodenta Swiss AG | 2013-03-28 | Traditional | PDF ↗ |
| K123870 | XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM | Megagen Implant Co., Ltd. | 2013-03-27 | Special | PDF ↗ |
| K130221 | HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM | Medimecca Co., Ltd. | 2013-03-21 | Special | PDF ↗ |
| K123415 | BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED | Biodenta Swiss AG | 2013-03-19 | Traditional | PDF ↗ |
| K120089 | BIOGENESIS IMPLANT SYSTEM | Biogenesis Co., Ltd. | 2013-03-13 | Traditional | PDF ↗ |
| K113042 | REVOIS IMPLANT SYSTEM | Riemser Arzneimittel AG | 2013-03-08 | Special | PDF ↗ |
| K121406 | INCLUSIVE TAPERED IMPLANT SYSTEM | Prismatik Dentalcraft, Inc. | 2013-02-22 | Traditional | PDF ↗ |
Product code DZE · Class II · Dental. Data: openFDA.