510(k) K181910

BracePaste MTP Light Cure Primer by American Orthodontics — Product Code KLE

K181910 is an FDA 510(k) premarket notification submitted by American Orthodontics for the device "BracePaste MTP Light Cure Primer". The FDA issued a decision of Substantially Equivalent on October 15, 2018. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. American Orthodontics has at least 10 other 510(k) clearances on record.