SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156

SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156 is an FDA 510(k)-cleared medical device (K001463) manufactured by Davis Schottlander & Davis, Ltd.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 15, 2000. Regulation: 8.