PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)

PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) is an FDA 510(k)-cleared medical device (K051464) 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 23, 2005. Regulation: 8.