The following data is part of a premarket notification filed by Osstem Implant Co., Ltd. with the FDA for Estar-z.
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ESTAR-Z 79308895 not registered Live/Pending |
OSSTEMIMPLANT CO., LTD. 2021-03-16 |