FDA 510(k) Applications Submitted by Hee Kyung Kwon
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160519 |
02/25/2016 |
Link Abutment for CEREC |
Osstem Implant Co., Ltd |
| K160670 |
03/10/2016 |
ET US SS Prosthetic system |
OSSTEM IMPLANT CO., LTD. |
| K161103 |
04/19/2016 |
US SA Implant 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. |
| K153015 |
10/15/2015 |
Transfer & Angled Abutment |
Osstem Implant Co., Ltd |
| K163088 |
11/04/2016 |
TSIII BA Fixture |
OSSTEM IMPLANT Co., Ltd. |
| K181690 |
06/26/2018 |
Clear-Jet Injection Catheter |
Finemedix Co. Ltd. |
| K183289 |
11/26/2018 |
ClearGrasp Snare |
Finemedix Co., Ltd. |
| K170736 |
03/10/2017 |
HySil Impression Materials |
Osstem Implant Co., Ltd.. |
| K151262 |
05/13/2015 |
Hyflex Heavy, Hyflex Mono, Hyflex Light |
Osstem Implant Co., Ltd |
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