COLTENE BRILLIANT LUX

COLTENE BRILLIANT LUX is an FDA 510(k)-cleared medical device (K840084) manufactured by Bauer, Cheng & Associates, 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 March 29, 1984. Regulation: 8.