K-number	K200614
Device name	FiteBac Antimicrobial Cavity Cleanser
Applicant	Largent Health, LLC
Product code	LBH
Device class	Class II
Decision date	Jun 25, 2020
Decision	Substantially Equivalent
Regulation	872.3260

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Source

View the full FDA submission: accessdata.fda.gov

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FiteBac Antimicrobial Cavity Cleanser

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