AUSTRY ALLOY(DENTAL BAKE-ON ALLOY)

AUSTRY ALLOY(DENTAL BAKE-ON ALLOY) is an FDA 510(k)-cleared medical device (K800994) manufactured by Howmedica 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 May 1, 1980. Regulation: 8.