510(k) K240153

Ceramic Etchant (HF-5 and HF-9) by Liaoning Upcera Co., Ltd. — Product Code KLE

K240153 is an FDA 510(k) premarket notification submitted by Liaoning Upcera Co., Ltd. for the device "Ceramic Etchant (HF-5 and HF-9)". The FDA issued a decision of Substantially Equivalent on October 2, 2024. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Liaoning Upcera Co., Ltd. has at least 9 other 510(k) clearances on record.