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 3 of 16
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K201225 | Neodent Implant System - GM Helix Implants 7.0 | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2020-09-04 | Traditional | PDF ↗ |
| K200102 | MIS Dental Implant System | Dentsply Sirona | 2020-09-03 | Traditional | PDF ↗ |
| K192062 | Nucleoss T6 Dental Implant System | Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST | 2020-08-27 | Traditional | PDF ↗ |
| K201981 | Magicore System | Innobiosurg Co., Ltd. | 2020-08-27 | Special | PDF ↗ |
| K200586 | Straumann TLX Implant System | Institut Straumann AG | 2020-08-20 | Traditional | PDF ↗ |
| K201334 | Keystone Dental XL Dental Implant System | Keystone Dental, Inc. | 2020-08-18 | Traditional | PDF ↗ |
| K192294 | I Do | I DO Biotech Co., Ltd. | 2020-07-31 | Traditional | PDF ↗ |
| K182081 | JDentalCare Implant System JDIcon | Jdentalcare Srl | 2020-06-26 | Traditional | PDF ↗ |
| K191443 | MSDI Dental Implants System | Medical Systems and Devices International , Ltd. | 2020-06-26 | Traditional | PDF ↗ |
| K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts | Implant Direct Sybron Manufacturing, LLC | 2020-06-25 | Traditional | PDF ↗ |
| K190637 | Fit & Brilliant Dental Implant System | F&B Technology Co., Ltd. | 2020-06-19 | Traditional | PDF ↗ |
| K193234 | NUVO IF Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2020-06-18 | Traditional | PDF ↗ |
| K192274 | BV Dental Implant System | Bio Concept Co., Ltd. | 2020-06-18 | Traditional | PDF ↗ |
| K193096 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2020-05-14 | Traditional | PDF ↗ |
| K192651 | ZAGA Zygomatic System | Southern Implants (Pty), Ltd. | 2020-05-07 | Traditional | PDF ↗ |
| K192197 | Magicore II System | Innobiosurg Co., Ltd. | 2020-04-28 | Traditional | PDF ↗ |
| K200867 | Implantswiss Dental Implant System and Implantswiss Dental Abutment System | Novodent SA | 2020-04-28 | Special | PDF ↗ |
| K193592 | Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2020-04-28 | Special | PDF ↗ |
| K200099 | s-Clean SQ-SL Implant System Mini | Dentis Co., Ltd. | 2020-04-13 | Traditional | PDF ↗ |
| K192015 | Faico Dental Implant System | Faico Medical, LLC | 2020-04-03 | Traditional | PDF ↗ |
| K200188 | DSI Dental Implant System | Dsi Dental Solutions, Ltd. | 2020-04-01 | Traditional | PDF ↗ |
| K190919 | ST Internal Implant System | T-Plus Implant Tech. Co., Ltd. | 2020-02-27 | Traditional | PDF ↗ |
| K190641 | AR_N SLA Type Implant System | Biotem Co., Ltd. | 2020-02-21 | Traditional | PDF ↗ |
| K190406 | SDS2.2 dental implant | Sds Swiss Dental Solutions AG | 2020-02-20 | Traditional | PDF ↗ |
| K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020-02-13 | Traditional | PDF ↗ |
| K190192 | K3Pro Konus New Abutments and Implants | Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG | 2020-02-10 | Traditional | PDF ↗ |
| K192688 | s-Clean SQ-SL Implant System Regular | Dentis Co., Ltd. | 2020-02-04 | Traditional | PDF ↗ |
| K190837 | Internal Hex Implant System | Ebi, Inc. | 2020-01-22 | Traditional | PDF ↗ |
| K190243 | Z5-BL | Z-Systems AG | 2020-01-03 | Traditional | PDF ↗ |
| K191256 | Straumann BLX Ø3.5 mm Implants | Institut Straumann AG | 2019-12-27 | Traditional | PDF ↗ |
| K191751 | EM Provisional | Hiossen, Inc. | 2019-12-16 | Abbreviated | PDF ↗ |
| K192149 | MIS Dental Implant System | Dentsply Sirona, Inc. | 2019-12-11 | Traditional | PDF ↗ |
| K191895 | Straumann Mini Implants | Institut Straumann AG | 2019-12-09 | Traditional | PDF ↗ |
| K191054 | Southern Implants MAX Implant System | Southern Implants (Pty), Ltd. | 2019-12-09 | Traditional | PDF ↗ |
| K190552 | JJ Implant System | Jj Implants | 2019-12-06 | Traditional | PDF ↗ |
| K181953 | SDS1.2 dental implant | Sds Swiss Dental Solutions AG | 2019-11-20 | Traditional | PDF ↗ |
| K191201 | EM SA Implant System | Hiossen, Inc. | 2019-11-15 | Traditional | PDF ↗ |
| K192347 | ST Internal Implant System | Megagen Implant Co., Ltd. | 2019-11-14 | Traditional | PDF ↗ |
| K190958 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019-11-09 | Traditional | PDF ↗ |
| K192053 | W Zirconia Implants | Tav Medical , Ltd. | 2019-10-29 | Traditional | PDF ↗ |
| K182448 | AnyRidge Octa 1 Implant System | Megagen Implant Co., Ltd. | 2019-10-09 | Traditional | PDF ↗ |
| K191127 | Advanced Intermezzo Implant System | Megagen Implant Co., Ltd. | 2019-10-08 | Traditional | PDF ↗ |
| K182143 | ALFA GATE Dental Implants System | Alfa Gate Mazen, Ltd. | 2019-10-03 | Traditional | PDF ↗ |
| K182219 | SGS Dental Implants System | Sgs International, Ltd. | 2019-08-29 | Traditional | PDF ↗ |
| K190849 | IS-III active System_S-narrow Type | Neobiotech Co., Ltd. | 2019-08-14 | Traditional | PDF ↗ |
| K182908 | Ziacom Dental Implant Systems | Ziacom Medical, S.L. | 2019-07-18 | Traditional | PDF ↗ |
| K190718 | Zygomatic Implants | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019-07-11 | Traditional | PDF ↗ |
| K182615 | Surgikor Dental Implant System | Surgikor, LLC | 2019-07-08 | Traditional | PDF ↗ |
| K180365 | PRAMA White Implant Systems | Sweden & Martina S.P.A. | 2019-07-08 | Traditional | PDF ↗ |
| K180968 | AlphaDent Implants Dental Implants System | Alphadent Implants, Ltd. | 2019-07-03 | Traditional | PDF ↗ |
| K190662 | MRI Compatibility for Existing Straumann Dental Implant Systems | Straumann USA, LLC | 2019-06-17 | Traditional | PDF ↗ |
| K181157 | Conical Plus Implant System | Osseofuse International, Inc. | 2019-05-24 | Traditional | PDF ↗ |
| K183242 | ET IV SA Dental Implants | Hiossen, Inc. | 2019-05-21 | Special | PDF ↗ |
| K180924 | Reflect Implant System | Ids - Integrated Dental Systems | 2019-03-29 | Traditional | PDF ↗ |
| K182313 | BoneTrust Implant System | Medical Instinct Deutschland GmbH | 2019-03-11 | Abbreviated | PDF ↗ |
| K173418 | NobelParallel Conical Connection | Nobel Biocare AB | 2019-02-21 | Traditional | PDF ↗ |
| K182293 | OsseOne Dental Implant System | Synoross Dba Osseone | 2019-02-15 | Traditional | PDF ↗ |
| K180183 | Ritter Dental Implant System | Ritter Implants GmbH & Co. KG | 2019-01-24 | Traditional | PDF ↗ |
| K182620 | MRI Compatibility for Existing Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019-01-18 | Traditional | PDF ↗ |
| K180477 | Straumann PURE Ceramic Implant System | Institut Straumann AG | 2019-01-04 | Traditional | PDF ↗ |
| K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments | Institut Straumann AG | 2018-12-28 | Traditional | PDF ↗ |
| K182194 | UV Active Implant System | Dio Corporation | 2018-12-14 | Traditional | PDF ↗ |
| K180859 | PYRAMIDION Dental Implants and Prostheses | Dentack Implants, Ltd. | 2018-12-13 | Traditional | PDF ↗ |
| K183069 | NobelZygoma 0° | Nobel Biocare AB | 2018-12-04 | Special | PDF ↗ |
| K173701 | Implant-One System | Implant Logistics, Inc. | 2018-11-29 | Traditional | PDF ↗ |
| K181137 | IT-III active System | Neobiotech Co., Ltd. | 2018-11-16 | Traditional | PDF ↗ |
| K181850 | Inversa Implants | Southern Implants (Pty), Ltd. | 2018-11-14 | Traditional | PDF ↗ |
| K172668 | W Zirconia Implants | Tav Medical , Ltd. | 2018-11-06 | Traditional | PDF ↗ |
| K181266 | Implantswiss Dental Implant System, Implantswiss Dental Abutment System | Novodent SA | 2018-11-01 | Traditional | PDF ↗ |
| K170732 | Biomate Dental Implant System | Biomate Medical Devices Technology Co., Ltd. | 2018-10-26 | Traditional | PDF ↗ |
| K182070 | BioHorizons Tapered IM Implants | BioHorizons Implant Systems, Inc. | 2018-10-10 | Special | PDF ↗ |
| K181138 | IS-III active System | Neobiotech Co., Ltd. | 2018-10-03 | Traditional | PDF ↗ |
| K173141 | CSM Submerged3-L Implant System | Csm Implant | 2018-09-19 | Traditional | PDF ↗ |
| K180465 | Provata Implant System | Southern Implants (Pty), Ltd. | 2018-09-06 | Traditional | PDF ↗ |
| K180536 | Neodent Implant System GM Line | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2018-08-30 | Traditional | PDF ↗ |
| K173575 | OsteoReady Dental Implant System | Osteoready, LLC | 2018-08-17 | Traditional | PDF ↗ |
| K173257 | BTI Dental Implant System UnicCa | B.T.I. Biotechnology Institute, Sl. | 2018-08-17 | Traditional | PDF ↗ |
| K173819 | MyPlant II Implant System | Hager& Meisinger GmbH | 2018-08-09 | Traditional | PDF ↗ |
| K180598 | UNIQA Dental Implants System | Uniqa Dental, Ltd. | 2018-08-08 | Traditional | PDF ↗ |
| K181178 | S-mini active Fixture | Neobiotech Co., Ltd. | 2018-07-24 | Traditional | PDF ↗ |
| K171197 | Zuga Dental Implant System | Zuga Medical, Inc. | 2018-06-30 | Traditional | PDF ↗ |
| K173116 | KJ ZIRCONIA Implant System | Kj Meditech Co., Ltd. | 2018-06-28 | Traditional | PDF ↗ |
| K180282 | MIS Internal Hex Dental Implant System | Mis Implants Technologies , Ltd. | 2018-06-22 | Traditional | PDF ↗ |
| K172345 | IU Implant System | Warantec Co., Ltd. | 2018-06-18 | Traditional | PDF ↗ |
| K172821 | Ti-one 101 TS Dental Implant System | Hung Chun Bio-S Co., Ltd. | 2018-06-11 | Traditional | PDF ↗ |
| K173706 | Piccolo Implants and Accessories | Southern Implants (Pty), Ltd. | 2018-06-08 | Traditional | PDF ↗ |
| K173961 | Straumann BLX Implant System | Institut Straumann AG | 2018-06-05 | Traditional | PDF ↗ |
| K173975 | UF(II) Wide Fixture | Dio Corporation | 2018-06-01 | Traditional | PDF ↗ |
| K173938 | IS-III HActive Fixture | Neobiotech Co., Ltd. | 2018-05-24 | Traditional | PDF ↗ |
| K180360 | OKTAGON Implant System | Hager& Meisinger GmbH | 2018-05-10 | Traditional | PDF ↗ |
| K172100 | URIS OMNI System | Truabutment, Inc. | 2018-05-04 | Traditional | PDF ↗ |
| K170776 | DTI-1 SLA IMPLANT SYSTEM | Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi | 2018-04-10 | Traditional | PDF ↗ |
| K173207 | SIC invent Dental Implant Systems | Sic Invent AG | 2018-04-05 | Abbreviated | PDF ↗ |
| K172630 | Kisses Plus Implant System | Achimhai Medical Corporation | 2018-04-03 | Traditional | PDF ↗ |
| K170608 | UF(II) Implant System | Dio Corporation | 2018-03-30 | Traditional | PDF ↗ |
| K173343 | Zygomatic Implant System | Southern Implants (Pty), Ltd. | 2018-02-27 | Traditional | PDF ↗ |
| K170131 | TAV Medical Dental Implants System | Tav Medical , Ltd. | 2018-02-10 | Traditional | PDF ↗ |
| K171179 | BR Type Implant System | Biotem Co., Ltd. | 2018-02-09 | Traditional | PDF ↗ |
| K171297 | AR_N Type Implant System | Biotem Co., Ltd. | 2018-01-31 | Traditional | PDF ↗ |
| K172240 | SPI Dental Implant System | Msi France | 2018-01-31 | Traditional | PDF ↗ |
Product code DZE · Class II · Dental. Data: openFDA.