ENIGMA HI-BASE DENTURE BASE MATERIAL

ENIGMA HI-BASE DENTURE BASE MATERIAL is an FDA 510(k)-cleared medical device (K993717) 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 December 21, 1999. Regulation: 8.