CUTTERSIL ACTIVATOR UNIVERSAL PLUS

CUTTERSIL ACTIVATOR UNIVERSAL PLUS is an FDA 510(k)-cleared medical device (K080338) manufactured by Heraeus Kulzer,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 20, 2008. Regulation: 8.