510(k) K013824

ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH by Dental Manufacturing S.P.A — Product Code ELM

K013824 is an FDA 510(k) premarket notification submitted by Dental Manufacturing S.P.A for the device "ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH". The FDA issued a decision of Substantially Equivalent on January 30, 2002. The device falls under product code ELM (Denture, Plastic, Teeth), a Class II device regulated under 21 CFR 872.3590. Dental Manufacturing S.P.A has at least 1 other 510(k) clearance on record.