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510(k) K250063

ARENA Star, Galaxy Star by Arum Dentistry Co., Ltd. — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2025
Date Received
January 10, 2025
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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