K-number	K201785
Device name	EPIEN Dental Cleanser
Applicant	Epien Medical, Inc.
Product code	KJJ
Device class	Class U
Decision date	Sep 9, 2021
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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EPIEN Dental Cleanser

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