DURAGARD SODIUM FLUORIDE VARNISH

DURAGARD SODIUM FLUORIDE VARNISH is an FDA 510(k)-cleared medical device (K002581) manufactured by Sultan Dental Products, Ltd.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 19, 2000. Regulation: 8.