510(k) K252785

TopCEM Vigor SA Self-Adhesive Resin Cement by Rizhao Huge Biomaterials Company, Ltd. — Product Code EMA

K252785 is an FDA 510(k) premarket notification submitted by Rizhao Huge Biomaterials Company, Ltd. for the device "TopCEM Vigor SA Self-Adhesive Resin Cement". The FDA issued a decision of Substantially Equivalent on December 12, 2025. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Rizhao Huge Biomaterials Company, Ltd. has at least 10 other 510(k) clearances on record.