DENTIN DISCLOSING GEL AND GEL REMOVER

DENTIN DISCLOSING GEL AND GEL REMOVER is an FDA 510(k)-cleared medical device (K896658) manufactured by Pulpdent Corp.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 13, 1990. Regulation: 8.