510(k) K181236

HySil Impression Materials by Osstem Implant Co., Ltd. — Product Code ELW

K181236 is an FDA 510(k) premarket notification submitted by Osstem Implant Co., Ltd. for the device "HySil Impression Materials". The FDA issued a decision of Substantially Equivalent on September 13, 2018. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Osstem Implant Co., Ltd. has at least 10 other 510(k) clearances on record.