ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD

ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD is an FDA 510(k)-cleared medical device (K972249) manufactured by Pelton & Crane 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 September 11, 1997. Regulation: 8.