EXPASYL POWER APPLICATOR

EXPASYL POWER APPLICATOR is an FDA 510(k)-cleared medical device (K051933) manufactured by Sybron Dental Specialties, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 2, 2006. Regulation: 8.