PULPDENT SEAL-RITE UDMA

PULPDENT SEAL-RITE UDMA is an FDA 510(k)-cleared medical device (K963921) 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 November 11, 1996. Regulation: 8.