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510(k) K231347

BruxZir™ TintEFX Coloring Liquid by Prismatik Dentalcraft, Inc. — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2023
Date Received
May 9, 2023
Clearance Type
Special
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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