510(k) K242530

HF-Etchant Hydrofluoric Acid Etching Gel by Rizhao Huge Biomaterials Company, Ltd. — Product Code KLE

K242530 is an FDA 510(k) premarket notification submitted by Rizhao Huge Biomaterials Company, Ltd. for the device "HF-Etchant Hydrofluoric Acid Etching Gel". The FDA issued a decision of Substantially Equivalent on December 20, 2024. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Rizhao Huge Biomaterials Company, Ltd. has at least 10 other 510(k) clearances on record.