510(k) K213890

IMICRYL Impression Materials by Imicryl Dis Malzemeleri San. VE Tic. A.S. — Product Code ELW

K213890 is an FDA 510(k) premarket notification submitted by Imicryl Dis Malzemeleri San. VE Tic. A.S. for the device "IMICRYL Impression Materials". The FDA issued a decision of Substantially Equivalent on February 11, 2022. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660.