510(k) K251124

G-Bond Universal by GC America, Inc. — Product Code KLE

K251124 is an FDA 510(k) premarket notification submitted by GC America, Inc. for the device "G-Bond Universal". The FDA issued a decision of Substantially Equivalent on October 2, 2025. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. GC America, Inc. has at least 10 other 510(k) clearances on record.