YAMAHACHI DENTURE BASE RESINS

YAMAHACHI DENTURE BASE RESINS is an FDA 510(k)-cleared medical device (K131036) manufactured by Yamahachi Dental Manufacturing Co.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 11, 2013. Regulation: 8.