510(k) K222741

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) by Hdi, Inc. — Product Code ELW

K222741 is an FDA 510(k) premarket notification submitted by Hdi, Inc. for the device "DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)". The FDA issued a decision of Substantially Equivalent on November 7, 2022. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Hdi, Inc. has at least 1 other 510(k) clearance on record.