CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL

CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL is an FDA 510(k)-cleared medical device (K873689) manufactured by Dentsply Intl.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 25, 1987. Regulation: 8.