FiteBac Antimicrobial Cavity Cleanser

Varnish, Cavity

Largent Health, LLC

The following data is part of a premarket notification filed by Largent Health, Llc with the FDA for Fitebac Antimicrobial Cavity Cleanser.

Pre-market Notification Details

Device IDK200614
510k NumberK200614
Device Name:FiteBac Antimicrobial Cavity Cleanser
ClassificationVarnish, Cavity
Applicant Largent Health, LLC 3698 Largent Way NW, Suite 101 Marietta,  GA  30064
ContactKirk Kimmerling
CorrespondentElizabeth O’keeffe
Secure BioMed Evalutations 7828 Hickory Flat Highway Suite 120 Woodstock,  GA  30188
Product CodeLBH  
CFR Regulation Number872.3260 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-09
Decision Date2020-06-25

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