510(k) K253248

Bright Cavity Liner by Dmp Dental Industry S.A. — Product Code EJK

K253248 is an FDA 510(k) premarket notification submitted by Dmp Dental Industry S.A. for the device "Bright Cavity Liner". The FDA issued a decision of Substantially Equivalent on January 13, 2026. The device falls under product code EJK (Liner, Cavity, Calcium Hydroxide), a Class II device regulated under 21 CFR 872.3250. Dmp Dental Industry S.A. has at least 2 other 510(k) clearances on record.