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510(k) K223253

Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) by Arum Dentistry Co., Ltd. — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2023
Date Received
October 21, 2022
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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