PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE

PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE is an FDA 510(k)-cleared medical device (K912194) manufactured by Jelenko Co.. 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 29, 1991. Regulation: 8.