REIGNING DENTURE MADE OF POLYCARB. RESIN

REIGNING DENTURE MADE OF POLYCARB. RESIN is an FDA 510(k)-cleared medical device (K801234) manufactured by Oki Shiks USA , 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 8, 1980. Regulation: 8.