Oral-B 5% Sodium Fluoride Varnish

Varnish, Cavity

YOUNG DENTAL MANUFACTURING CO 1, LLC.

The following data is part of a premarket notification filed by Young Dental Manufacturing Co 1, Llc. with the FDA for Oral-b 5% Sodium Fluoride Varnish.

Pre-market Notification Details

Device IDK153334
510k NumberK153334
Device Name:Oral-B 5% Sodium Fluoride Varnish
ClassificationVarnish, Cavity
Applicant YOUNG DENTAL MANUFACTURING CO 1, LLC. 13705 SHORELINE CT. EAST Earth City,  MO  63045
ContactSarah Moore
CorrespondentSarah Moore
YOUNG DENTAL MANUFACTURING CO 1, LLC. 13705 SHORELINE CT. EAST Earth City,  MO  63045
Product CodeLBH  
CFR Regulation Number872.3260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-19
Decision Date2016-05-20
Summary:summary

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