
Elevate Oral Care
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SMARTCOAT 2.5% NAF VARNISH is an FDA 510(k)-cleared medical device (K131376) manufactured by Elevate Oral Care. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 26, 2013. Regulation: 8.