
Pac-Dent International, Inc.
Free shipping on orders over $99 · 30-day returns
PROFLUORO FLUORIDE VARNISH is an FDA 510(k)-cleared medical device (K141422) manufactured by Pac-Dent International, 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 29, 2014. Regulation: 8.