HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)

HOFFMANN'S CEMENT (PHOSPHATE, NORMAL) is an FDA 510(k)-cleared medical device (K123273) 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 December 6, 2012. Regulation: 8.