SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT

SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT is an FDA 510(k)-cleared medical device (K931857) manufactured by Confi-Dental Products Co.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 21, 1993. Regulation: 8.