510(k) K153334

Oral-B 5% Sodium Fluoride Varnish by Young Dental Manufacturing Co. 1, LLC — Product Code LBH

K153334 is an FDA 510(k) premarket notification submitted by Young Dental Manufacturing Co. 1, LLC for the device "Oral-B 5% Sodium Fluoride Varnish". The FDA issued a decision of Substantially Equivalent on May 20, 2016. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Young Dental Manufacturing Co. 1, LLC has at least 10 other 510(k) clearances on record.