PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT

PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT is an FDA 510(k)-cleared medical device (K011619) manufactured by Planmeca Oy. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 28, 2001. Regulation: 8.