FDA 510(k) Applications Submitted by Osstem Implant CO., LTD.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160670 |
03/10/2016 |
ET US SS Prosthetic system |
OSSTEM IMPLANT CO., LTD. |
| K161604 |
06/10/2016 |
OSSTEM Implant System |
OSSTEM IMPLANT CO., LTD. |
| K161689 |
06/20/2016 |
OSSTEM Implant System - Abutment |
OSSTEM IMPLANT Co., Ltd. |
| K163088 |
11/04/2016 |
TSIII BA Fixture |
OSSTEM IMPLANT Co., Ltd. |
| K183347 |
12/03/2018 |
K3 |
Osstem Implant Co., Ltd. |
| K210041 |
01/07/2021 |
HySil Plus Impression Materials |
Osstem Implant Co., Ltd. |
| K212303 |
07/23/2021 |
T2 |
Osstem Implant Co., Ltd. |
| K183475 |
12/17/2018 |
T1-CS, T1-C |
Osstem Implant Co., Ltd. |
| K210097 |
01/14/2021 |
Estar-Z |
Osstem Implant Co., Ltd. |
| K182091 |
08/03/2018 |
Osstem Abutment System |
Osstem Implant Co., Ltd. |
| K182881 |
10/15/2018 |
Bone Screw, Bone Tack |
Osstem Implant Co., Ltd. |
| K192941 |
10/18/2019 |
HySil Super Fast Impression Materials |
Osstem Implant Co., Ltd. |
| K163557 |
12/19/2016 |
SS SA Fixture |
OSSTEM IMPLANT Co., Ltd. |
| K161197 |
04/28/2016 |
Orthodontic Screw |
OSSTEM IMPLANT CO., LTD. |
| K140507 |
02/27/2014 |
HIOSSEN PROSTHETIC SYSTEM |
OSSTEM IMPLANT CO., LTD. |
| K140600 |
03/10/2014 |
SB ANCHOR |
OSSTEM IMPLANT CO., LTD. |
| K221684 |
06/10/2022 |
Osstem Abutment System |
Osstem Implant Co., Ltd. |
| K222778 |
09/14/2022 |
Osstem Implant System |
Osstem Implant CO., LTD. |
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