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510(k) K190758

Opus Bulk Fill APS, Opus Bulk Fill Flow APS by Dentscare Ltda — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2019
Date Received
March 25, 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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