HELIOFORM GOLD-BASED ALLOY

HELIOFORM GOLD-BASED ALLOY is an FDA 510(k)-cleared medical device (K990670) manufactured by C. Hafner GmbH & 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 April 1, 1999. Regulation: 8.