
Ultradent Products, Inc.
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VALO Grand Corded and Accessory Lenses is an FDA 510(k)-cleared medical device (K210550) 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 February 28, 2021. Regulation: 8.