M-65 GOLD BASE DENTAL ALLOY

M-65 GOLD BASE DENTAL ALLOY is an FDA 510(k)-cleared medical device (K891528) manufactured by Macdonald Metals and Ceramics. 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 11, 1989. Regulation: 8.