510(k) K251578

BEAUTIFIL II by Shofu Dental Corporation — Product Code EBF

K251578 is an FDA 510(k) premarket notification submitted by Shofu Dental Corporation for the device "BEAUTIFIL II". The FDA issued a decision of Substantially Equivalent on May 27, 2025. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Shofu Dental Corporation has at least 10 other 510(k) clearances on record.