510(k) K212475

Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) by Prevest Denpro Limited — Product Code EJK

K212475 is an FDA 510(k) premarket notification submitted by Prevest Denpro Limited for the device "Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)". The FDA issued a decision of Substantially Equivalent on May 13, 2022. The device falls under product code EJK (Liner, Cavity, Calcium Hydroxide), a Class II device regulated under 21 CFR 872.3250. Prevest Denpro Limited has at least 6 other 510(k) clearances on record.