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510(k) K190597

BRILLIANT EverGlow Flow by Coltene/Whaledent AG — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2019
Date Received
March 7, 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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  • K112168 — COMPONEER (November 21, 2011)
  • K083304 — TEMPOSIL 2 (February 6, 2009)

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