ORTHOPHOS 3/3 CEPH/3 DS

ORTHOPHOS 3/3 CEPH/3 DS is an FDA 510(k)-cleared medical device (K990528) 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 April 29, 1999. Regulation: 8.