510(k) K214086

Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty by Genoss Co., Ltd. — Product Code ELW

K214086 is an FDA 510(k) premarket notification submitted by Genoss Co., Ltd. for the device "Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty". The FDA issued a decision of Substantially Equivalent on December 15, 2022. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Genoss Co., Ltd. has at least 10 other 510(k) clearances on record.