510(k) K201684

A-Silicone for Bite Registration by Shandong Huge Dental Material Corporation — Product Code ELW

K201684 is an FDA 510(k) premarket notification submitted by Shandong Huge Dental Material Corporation for the device "A-Silicone for Bite Registration". The FDA issued a decision of Substantially Equivalent on September 24, 2020. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Shandong Huge Dental Material Corporation has at least 8 other 510(k) clearances on record.