
Pulpdent Corporation
Free shipping on orders over $99 · 30-day returns
TUFF-TEMP 2.0 is an FDA 510(k)-cleared medical device (K120784) manufactured by Pulpdent Corporation. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 7, 2012. Regulation: 8.