
Austenal, Inc.
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VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOY is an FDA 510(k)-cleared medical device (K970205) manufactured by Austenal, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 20, 1997. Regulation: 8.