510(k) K251946

G aenial Universal Injectable II by GC America, Inc. — Product Code EBF

K251946 is an FDA 510(k) premarket notification submitted by GC America, Inc. for the device "G aenial Universal Injectable II". The FDA issued a decision of Substantially Equivalent on August 29, 2025. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. GC America, Inc. has at least 10 other 510(k) clearances on record.