
Ultradent Products, Inc.
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ULTRADENT PRODUCT PIT & FISSURE SEALANT PROD LINE is an FDA 510(k)-cleared medical device (K921598) 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 8, 1992. Regulation: 8.