Osstem Implant Co., Ltd.
68 FDA 510(k) clearances · Manufacturer
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| Record | Firm | Date |
|---|---|---|
| Healing Abutment System (K251434) | Osstem Implant Co., Ltd. | 2026-03-04 |
| Bone Screw (K251569) | Osstem Implant Co., Ltd. | 2025-08-13 |
| Estar-ZE (K242521) | Osstem Implant Co., Ltd. | 2024-11-20 |
| T2 Plus (K233806) | Osstem Implant Co., Ltd. | 2024-09-06 |
| TS Abutment System (K233194) | Osstem Implant Co., Ltd. | 2024-02-20 |
| SS Abutment System (K232220) | Osstem Implant Co., Ltd. | 2023-12-05 |
| N1 (K232012) | Osstem Implant Co., Ltd. | 2023-11-28 |
| Osstem Implant System (K222778) | Osstem Implant Co., Ltd. | 2023-09-23 |
| Osstem Abutment System (K221684) | Osstem Implant Co., Ltd. | 2022-09-08 |
| T2 (K212303) | Osstem Implant Co., Ltd. | 2021-09-21 |
| Estar-Z (K210097) | Osstem Implant Co., Ltd. | 2021-07-02 |
| HySil Plus Impression Materials (K210041) | Osstem Implant Co., Ltd. | 2021-03-18 |
| HySil Super Fast Impression Materials (K192941) | Osstem Implant Co., Ltd. | 2020-01-30 |
| K3 (K183347) | Osstem Implant Co., Ltd. | 2019-09-04 |
| T1-CS, T1-C (K183475) | Osstem Implant Co., Ltd. | 2019-08-30 |
| Bone Screw, Bone Tack (K182881) | Osstem Implant Co., Ltd. | 2019-08-09 |
| Osstem Abutment System (K182091) | Osstem Implant Co., Ltd. | 2019-07-12 |
| OssBuilder System (K181854) | Osstem Implant Co., Ltd. | 2019-05-07 |
| HySil Impression Materials (K181236) | Osstem Implant Co., Ltd. | 2018-09-13 |
| OssBuilder System (K172354) | Osstem Implant Co., Ltd. | 2018-03-26 |
| HySil Impression Materials (K170736) | Osstem Implant Co., Ltd. | 2017-06-07 |
| OSSTEM Implant System - Abutment (K161689) | Osstem Implant Co., Ltd. | 2017-05-22 |
| SS SA Fixture (K163557) | Osstem Implant Co., Ltd. | 2017-05-15 |
| ET US SS Prosthetic system (K160670) | Osstem Implant Co., Ltd. | 2017-04-25 |
| TSIII BA Fixture (K163088) | Osstem Implant Co., Ltd. | 2017-04-21 |
| K3 (K152830) | Osstem Implant Co., Ltd. | 2017-04-20 |
| US SA Implant System (K161103) | Osstem Implant Co., Ltd. | 2017-02-02 |
| Orthodontic Screw (K161197) | Osstem Implant Co., Ltd. | 2016-12-21 |
| Transfer & Angled Abutment (K153015) | Osstem Implant Co., Ltd. | 2016-12-05 |
| Link Abutment for CEREC (K160519) | Osstem Implant Co., Ltd. | 2016-10-28 |
| OSSTEM Implant System (K161604) | Osstem Implant Co., Ltd. | 2016-10-17 |
| Hyflex Heavy, Hyflex Mono, Hyflex Light (K151262) | Osstem Implant Co., Ltd. | 2015-09-21 |
| PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO) (K141497) | Osstem Implant Co., Ltd. | 2014-08-26 |
| SB ANCHOR (K140600) | Osstem Implant Co., Ltd. | 2014-08-21 |
| HIOSSEN PROSTHETIC SYSTEM (K140507) | Osstem Implant Co., Ltd. | 2014-08-20 |
| ET PROSTHETIC SYSTEM (K130662) | Osstem Implant Co., Ltd. | 2014-01-10 |
| SMARTBUILDER SYSTEM (SB1) (K130840) | Osstem Implant Co., Ltd. | 2013-09-18 |
| PORTABLE X-RAY SYSTEM (K122124) | Osstem Implant Co., Ltd. | 2013-05-16 |
| MULTI ANGLED ABUTMENT (K123755) | Osstem Implant Co., Ltd. | 2013-04-26 |
| TS IMPLANT SYSTEM (K121585) | Osstem Implant Co., Ltd. | 2013-01-07 |
| NP-CAST ABUTMENT SYSTEM (K121843) | Osstem Implant Co., Ltd. | 2012-12-11 |
| TS FIXTURE SYSTEM (K121995) | Osstem Implant Co., Ltd. | 2012-11-29 |
| MS SA IMPLANT SYSTEM (K122171) | Osstem Implant Co., Ltd. | 2012-11-16 |
| SMARTBUILDER SYSTEM (K120951) | Osstem Implant Co., Ltd. | 2012-10-03 |
| ET/SS IMPLANT SYSTEM (K120847) | Osstem Implant Co., Ltd. | 2012-08-10 |
| PROSTHETIC SYSTEM (K110308) | Osstem Implant Co., Ltd. | 2011-10-03 |
| ORTHODONTIC SCREW (K103105) | Osstem Implant Co., Ltd. | 2011-03-25 |
| HS/HG PROSTHETIC SYSTEM (K100245) | Osstem Implant Co., Ltd. | 2010-08-17 |
| GS III SYSTEM (K091208) | Osstem Implant Co., Ltd. | 2010-03-03 |
| HG II SHORT FIXTURE SYSTEM (K091678) | Osstem Implant Co., Ltd. | 2010-02-18 |
| HS II SHORT FIXTURE SYSTEM (K083633) | Osstem Implant Co., Ltd. | 2009-05-01 |
| MS SYSTEM (K083067) | Osstem Implant Co., Ltd. | 2009-02-02 |
| ZIOCERA & CONVERTIBLE SYSTEM (K081786) | Osstem Implant Co., Ltd. | 2008-12-02 |
| GS III FIXTURE SYSTEM (K082213) | Osstem Implant Co., Ltd. | 2008-10-14 |
| MS SYSTEM (NARROW RIDGE) (K080594) | Osstem Implant Co., Ltd. | 2008-09-03 |
| HU/HS/HG PROSTHETIC SYSTEM (K081575) | Osstem Implant Co., Ltd. | 2008-09-02 |
| HG II FIXTURE SYSTEM (K080744) | Osstem Implant Co., Ltd. | 2008-07-17 |
| NT/IT SYSTEM (K081078) | Osstem Implant Co., Ltd. | 2008-07-15 |
| US/GS ULTRA WIDE SYSTEM (K073465) | Osstem Implant Co., Ltd. | 2008-04-07 |
| US/SS/GS SYSTEM (K073247) | Osstem Implant Co., Ltd. | 2008-03-07 |
| HU II / HS II FIXTURE SYSTEM (K080387) | Osstem Implant Co., Ltd. | 2008-03-07 |
| MS SYSTEM (DENTURE) (K072959) | Osstem Implant Co., Ltd. | 2008-02-04 |
| MS SYSTEM (PROVISIONAL) (K072871) | Osstem Implant Co., Ltd. | 2008-01-10 |
| GS FIXTURE SYSTEM (K072896) | Osstem Implant Co., Ltd. | 2007-11-06 |
| GS SYSTEM (K063861) | Osstem Implant Co., Ltd. | 2007-09-21 |
| US SYSTEM (K062030) | Osstem Implant Co., Ltd. | 2006-11-02 |
| SS SYSTEM (K062051) | Osstem Implant Co., Ltd. | 2006-11-01 |
| SUPER ORTHODONTIC SCREW (K062156) | Osstem Implant Co., Ltd. | 2006-10-20 |
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