510(k) K253236

G-BLOCK by Graphenano Dental S.L. — Product Code EBF

K253236 is an FDA 510(k) premarket notification submitted by Graphenano Dental S.L. for the device "G-BLOCK". The FDA issued a decision of Substantially Equivalent on September 29, 2025. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Graphenano Dental S.L. has at least 1 other 510(k) clearance on record.