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 IDK210097
510k NumberK210097
Device Name:Estar-Z
ClassificationPowder, Porcelain
Applicant Osstem Implant Co., Ltd. A-dong, 51, Mayu-ro 238beon-gil Siheung-si,  KR 15079
ContactJungmin Yoo
CorrespondentPeter Lee
Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills,  PA  19030
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-14
Decision Date2021-07-02

Trademark Results [Estar-Z]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ESTAR-Z
ESTAR-Z
79308895 not registered Live/Pending
OSSTEMIMPLANT CO., LTD.
2021-03-16

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