ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD

ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD is an FDA 510(k)-cleared medical device (K013650) manufactured by Sirona Dental Systems GmbH. 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 5, 2001. Regulation: 8.