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Etex Corp.
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ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE is an FDA 510(k)-cleared medical device (K091729) manufactured by Etex Corp.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 22, 2009. Regulation: 8.