510(k) K260485

Any-Etch by Mediclus Co., Ltd. — Product Code KLE

K260485 is an FDA 510(k) premarket notification submitted by Mediclus Co., Ltd. for the device "Any-Etch". The FDA issued a decision of Substantially Equivalent on May 14, 2026. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Mediclus Co., Ltd. has at least 10 other 510(k) clearances on record.