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510(k) K163568

SHOFU RESIN GLAZE by Shofu Dental Corporation — Product Code EBD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2017
Date Received
December 19, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coating, Filling Material, Resin
Device Class
Class II
Regulation Number
872.3310
Review Panel
DE
Submission Type

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