TRILUX, Z-TONE, ACRY ROCK

TRILUX, Z-TONE, ACRY ROCK is an FDA 510(k)-cleared medical device (K022299) manufactured by Ruthibras Imp. Exp. Com. DE Materiais Odontologico. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 6, 2002. Regulation: 8.