
3M Company
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VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247 is an FDA 510(k)-cleared medical device (K090519) manufactured by 3M Company. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 14, 2009. Regulation: 8.