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510(k) K190453

VisCalor bulk by Voco GmbH — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2019
Date Received
February 25, 2019
Clearance Type
Special
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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