Implant, Endosseous, Root-Form
Regulation 872.3640
19510(k)s in 12 months (1,550 all time)
2recalls in 12 months (212 all time)
192recalls that name a 510(k)
Top companies in DZE
| Company | 510(k)s | Recalls |
|---|---|---|
| Nobel Biocare AB | 33 | 37 |
| Biomet 3i | 11 | 52 |
| Nobelpharma AB | 52 | 0 |
| Zimmer Dental, Inc. | 19 | 30 |
| Straumann USA | 35 | 9 |
| Implant Innovations, Inc. | 37 | 4 |
| Steri-Oss, Inc. | 40 | 0 |
| BioHorizons Implant Systems, Inc. | 26 | 12 |
| Minimatic Implant Technology | 34 | 0 |
| Implant Center of the Palm Beaches | 32 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 23, 2020 | K202479 | IBS Implant System Innobiosurg Co., Ltd., KR | DZE |
| Sep 4, 2020 | K201225 | Neodent Implant System - GM Helix Implants 7.0 Jjgc Industria E Comercio DE Materiais Dentarios S.A., BR | DZE |
| Sep 3, 2020 | K200102 | MIS Dental Implant System Dentsply Sirona | DZE |
| Aug 27, 2020 | K201981 | Magicore System Innobiosurg Co., Ltd., KR | DZE |
| Aug 27, 2020 | K192062 | Nucleoss T6 Dental Implant System Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST, TR | DZE |
| Aug 20, 2020 | K200586 | Straumann TLX Implant System Institut Straumann AG, CH | DZE |
| Aug 18, 2020 | K201334 | Keystone Dental XL Dental Implant System Keystone Dental, Inc. | DZE |
| Jul 31, 2020 | K192294 | I Do I DO Biotech Co., Ltd., KR | DZE |
| Jun 26, 2020 | K191443 | MSDI Dental Implants System Medical Systems and Devices International , Ltd., IL | DZE |
| Jun 26, 2020 | K182081 | JDentalCare Implant System JDIcon Jdentalcare Srl, IT | DZE |
| Jun 25, 2020 | K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts Implant Direct Sybron Manufacturing, LLC | DZE |
| Jun 19, 2020 | K190637 | Fit & Brilliant Dental Implant System F&B Technology Co., Ltd., KR | DZE |
| Jun 18, 2020 | K193234 | NUVO IF Implant System Jjgc Industria E Comercio DE Materiais Dentarios S.A., BR | DZE |
| Jun 18, 2020 | K192274 | BV Dental Implant System Bio Concept Co., Ltd., CN | DZE |
| May 14, 2020 | K193096 | S.I.N. Dental Implant System S.I.N. - Sistema DE Implante Nacional S.A., BR | DZE |
| May 7, 2020 | K192651 | ZAGA Zygomatic System Southern Implants (Pty), Ltd., ZA | DZE |
| Apr 28, 2020 | K200867 | Implantswiss Dental Implant System and Implantswiss Dental Abutment System Novodent SA, CH | DZE |
| Apr 28, 2020 | K193592 | Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants Jjgc Industria E Comercio DE Materiais Dentarios S.A., BR | DZE |
| Apr 28, 2020 | K192197 | Magicore II System Innobiosurg Co., Ltd., KR | DZE |
| Apr 13, 2020 | K200099 | s-Clean SQ-SL Implant System Mini Dentis Co., Ltd., KR | DZE |
| Apr 3, 2020 | K192015 | Faico Dental Implant System Faico Medical, LLC | DZE |
| Apr 1, 2020 | K200188 | DSI Dental Implant System Dsi Dental Solutions, Ltd., IL | DZE |
| Feb 27, 2020 | K190919 | ST Internal Implant System T-Plus Implant Tech. Co., Ltd., TW | DZE |
| Feb 21, 2020 | K190641 | AR_N SLA Type Implant System Biotem Co., Ltd., KR | DZE |
| Feb 20, 2020 | K190406 | SDS2.2 dental implant Sds Swiss Dental Solutions AG, CH | DZE |
| Feb 13, 2020 | K183024 | Implacil Implant System Implacil DE Bortoli Material Odontologico Ltda, BR | DZE |
| Feb 10, 2020 | K190192 | K3Pro Konus New Abutments and Implants Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG, DE | DZE |
| Feb 4, 2020 | K192688 | s-Clean SQ-SL Implant System Regular Dentis Co., Ltd., KR | DZE |
| Jan 22, 2020 | K190837 | Internal Hex Implant System Ebi, Inc., KR | DZE |
| Jan 3, 2020 | K190243 | Z5-BL Z-Systems AG, CH | DZE |
| Dec 27, 2019 | K191256 | Straumann BLX Ø3.5 mm Implants Institut Straumann AG, CH | DZE |
| Dec 16, 2019 | K191751 | EM Provisional Hiossen, Inc. | DZE |
| Dec 11, 2019 | K192149 | MIS Dental Implant System Dentsply Sirona, Inc. | DZE |
| Dec 9, 2019 | K191895 | Straumann Mini Implants Institut Straumann AG, CH | DZE |
| Dec 9, 2019 | K191054 | Southern Implants MAX Implant System Southern Implants (Pty), Ltd., ZA | DZE |
| Dec 6, 2019 | K190552 | JJ Implant System Jj Implants, IN | DZE |
| Nov 20, 2019 | K181953 | SDS1.2 dental implant Sds Swiss Dental Solutions AG, CH | DZE |
| Nov 15, 2019 | K191201 | EM SA Implant System Hiossen, Inc. | DZE |
| Nov 14, 2019 | K192347 | ST Internal Implant System Megagen Implant Co., Ltd., KR | DZE |
| Nov 9, 2019 | K190958 | Neodent Implant System Jjgc Industria E Comercio DE Materiais Dentarios S.A., BR | DZE |
| Oct 29, 2019 | K192053 | W Zirconia Implants Tav Medical , Ltd., IL | DZE |
| Oct 9, 2019 | K182448 | AnyRidge Octa 1 Implant System Megagen Implant Co., Ltd., KR | DZE |
| Oct 8, 2019 | K191127 | Advanced Intermezzo Implant System Megagen Implant Co., Ltd., KR | DZE |
| Oct 3, 2019 | K182143 | ALFA GATE Dental Implants System Alfa Gate Mazen, Ltd., IL | DZE |
| Aug 29, 2019 | K182219 | SGS Dental Implants System Sgs International, Ltd., HU | DZE |
| Aug 14, 2019 | K190849 | IS-III active System_S-narrow Type Neobiotech Co., Ltd., KR | DZE |
| Jul 18, 2019 | K182908 | Ziacom Dental Implant Systems Ziacom Medical, S.L., ES | DZE |
| Jul 11, 2019 | K190718 | Zygomatic Implants Jjgc Industria E Comercio DE Materiais Dentarios S.A., BR | DZE |
| Jul 8, 2019 | K182615 | Surgikor Dental Implant System Surgikor, LLC | DZE |
| Jul 8, 2019 | K180365 | PRAMA White Implant Systems Sweden & Martina S.P.A., IT | DZE |
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