
Dental Manufacturing S.P.A
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ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH is an FDA 510(k)-cleared medical device (K013824) manufactured by Dental Manufacturing S.P.A. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 29, 2002. Regulation: 8.