TEMREX-DENTIN VARNISH

TEMREX-DENTIN VARNISH is an FDA 510(k)-cleared medical device (K851030) manufactured by Temrex Corp.. 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 19, 1985. Regulation: 8.