510(k) K150128

GC Ortho Connect, GC Ortho Etching Gel by Gc Orthodontics America, Inc. — Product Code DYH

K150128 is an FDA 510(k) premarket notification submitted by Gc Orthodontics America, Inc. for the device "GC Ortho Connect, GC Ortho Etching Gel". The FDA issued a decision of Substantially Equivalent on July 16, 2015. The device falls under product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin), a Class II device regulated under 21 CFR 872.3750. Gc Orthodontics America, Inc. has at least 1 other 510(k) clearance on record.