HERCULITE XR & XRV

HERCULITE XR & XRV is an FDA 510(k)-cleared medical device (K943642) 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 November 16, 1994. Regulation: 8.