510(k) K261840

BracePaste Prime Plus by American Orthodontics — Product Code DYH

K261840 is an FDA 510(k) premarket notification submitted by American Orthodontics for the device "BracePaste Prime Plus". The FDA issued a decision of Substantially Equivalent on June 3, 2026. 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 has at least 10 other 510(k) clearances on record.