510(k) K171562

Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono by Dreve Dentamid GmbH — Product Code ELW

K171562 is an FDA 510(k) premarket notification submitted by Dreve Dentamid GmbH for the device "Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono". The FDA issued a decision of Substantially Equivalent on April 13, 2018. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Dreve Dentamid GmbH has at least 5 other 510(k) clearances on record.