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Ultradent Products, Inc.
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FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502 is an FDA 510(k)-cleared medical device (K051750) 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 18, 2005. Regulation: 8.