PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS

PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS is an FDA 510(k)-cleared medical device (K130076) manufactured by Merz Dental 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 August 21, 2013. Regulation: 8.