K-number	K153334
Device name	Oral-B 5% Sodium Fluoride Varnish
Applicant	Young Dental Manufacturing Co. 1, LLC
Product code	LBH
Device class	Class II
Decision date	May 20, 2016
Decision	Substantially Equivalent
Regulation	872.3260

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View the full FDA submission: accessdata.fda.gov

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Oral-B 5% Sodium Fluoride Varnish

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