KERALLOY NON-GAMMA 2 AMALGAM

KERALLOY NON-GAMMA 2 AMALGAM is an FDA 510(k)-cleared medical device (K912992) manufactured by Wilde-USA, 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 November 12, 1991. Regulation: 8.