
Austenal Dental, Inc.
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COBALT, 29.5% CHROMIUM ALLOY DENTAL BAKE-ON ALLOY is an FDA 510(k)-cleared medical device (K862667) manufactured by Austenal Dental, 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 July 30, 1986. Regulation: 8.