
Young Dental Manufacturing Co. 1, LLC
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Oral-B 5% Sodium Fluoride Varnish is an FDA 510(k)-cleared medical device (K153334) manufactured by Young Dental Manufacturing Co. 1, LLC. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 19, 2016. Regulation: 8.