
I.T.C. Ent.
Free shipping on orders over $99 · 30-day returns
PRIMODENT ACRYLIC TEETH is an FDA 510(k)-cleared medical device (K926070) manufactured by I.T.C. Ent.. 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 16, 1994. Regulation: 8.