K-number	K190597
Device name	BRILLIANT EverGlow Flow
Applicant	Coltene/Whaledent AG
Product code	EBF
Device class	Class II
Decision date	Jun 21, 2019
Decision	Substantially Equivalent
Regulation	872.3690

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Source

View the full FDA submission: accessdata.fda.gov

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BRILLIANT EverGlow Flow

Everything you need for a 510(k) submission. Nothing you don't.