
Ultradent Products, Inc.
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ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE is an FDA 510(k)-cleared medical device (K921600) manufactured by Ultradent Products, 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 September 27, 1992. Regulation: 8.