510(k) K242572

TopCEM-Try in Veneer Try-in Gel by Rizhao Huge Biomaterials Company, Ltd. — Product Code EBF

K242572 is an FDA 510(k) premarket notification submitted by Rizhao Huge Biomaterials Company, Ltd. for the device "TopCEM-Try in Veneer Try-in Gel". The FDA issued a decision of Substantially Equivalent on December 20, 2024. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Rizhao Huge Biomaterials Company, Ltd. has at least 10 other 510(k) clearances on record.