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510(k) K191389

Allcem Veneer APS by Dentscare Ltda — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2020
Date Received
May 24, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

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