510(k) K242675

FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) by Spident Co., Ltd. — Product Code KLE

K242675 is an FDA 510(k) premarket notification submitted by Spident Co., Ltd. for the device "FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)". The FDA issued a decision of Substantially Equivalent on November 1, 2024. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Spident Co., Ltd. has at least 10 other 510(k) clearances on record.