510(k) K242537

BracePaste Fluoride Sealant by American Orthodontics Corp. — Product Code DYH

K242537 is an FDA 510(k) premarket notification submitted by American Orthodontics Corp. for the device "BracePaste Fluoride Sealant". The FDA issued a decision of Substantially Equivalent on August 27, 2024. The device falls under product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin), a Class II device regulated under 21 CFR 872.3750. American Orthodontics Corp. has at least 10 other 510(k) clearances on record.