FiteBac 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 Cavity Cleanser.

Pre-market Notification Details

Device IDK190271
510k NumberK190271
Device Name:FiteBac Cavity Cleanser
ClassificationVarnish, Cavity
Applicant Largent Health, LLC 3698 Largent Way NW, Suite 101 Marietta,  GA  30064
ContactKirk Kimmerling
CorrespondentElizabeth O'keeffe
Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock,  GA  30188
Product CodeLBH  
CFR Regulation Number872.3260 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-08
Decision Date2020-01-23
Summary:summary

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