510(k) K214054

TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 by Tp Orthodontics, Inc. — Product Code DYH

K214054 is an FDA 510(k) premarket notification submitted by Tp Orthodontics, Inc. for the device "TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520". The FDA issued a decision of Substantially Equivalent on October 14, 2022. The device falls under product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin), a Class II device regulated under 21 CFR 872.3750. Tp Orthodontics, Inc. has at least 4 other 510(k) clearances on record.