FIBERLITE, FIBERLITE HS AND FIBERSEAL

FIBERLITE, FIBERLITE HS AND FIBERSEAL is an FDA 510(k)-cleared medical device (K884038) manufactured by Jeneric/Pentron, 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 December 6, 1988. Regulation: 8.