SOWELL COBALT-CHROME METAL ALLOY

SOWELL COBALT-CHROME METAL ALLOY is an FDA 510(k)-cleared medical device (K973567) manufactured by C.K. International Trading. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 10, 1997. Regulation: 8.