510(k) K844349

SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS by Ivoclar USA, Inc. — Product Code ELM

K844349 is an FDA 510(k) premarket notification submitted by Ivoclar USA, Inc. for the device "SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS". The FDA issued a decision of Substantially Equivalent on December 3, 1984. The device falls under product code ELM (Denture, Plastic, Teeth), a Class II device regulated under 21 CFR 872.3590. Ivoclar USA, Inc. has at least 10 other 510(k) clearances on record.