Estar-Z
Powder, Porcelain
Osstem Implant Co., Ltd.
The following data is part of a premarket notification filed by Osstem Implant Co., Ltd. with the FDA for Estar-z.
Pre-market Notification Details
| Device ID | K210097 |
| 510k Number | K210097 |
| Device Name: | Estar-Z |
| Classification | Powder, Porcelain |
| Applicant | Osstem Implant Co., Ltd. A-dong, 51, Mayu-ro 238beon-gil Siheung-si, KR 15079 |
| Contact | Jungmin Yoo |
| Correspondent | Peter Lee Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-14 |
| Decision Date | 2021-07-02 |
Trademark Results [Estar-Z]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ESTAR-Z 79308895 not registered Live/Pending |
OSSTEMIMPLANT CO., LTD. 2021-03-16 |
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