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510(k) K210097

Estar-Z by Osstem Implant Co., Ltd. — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2021
Date Received
January 14, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powder, Porcelain
Device Class
Class II
Regulation Number
872.6660
Review Panel
DE
Submission Type

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