MINERAL TRIOXIDE AGGREGATE (MTA)

MINERAL TRIOXIDE AGGREGATE (MTA) is an FDA 510(k)-cleared medical device (K964174) manufactured by Tulsa Dental Products, Ltd.. 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 9, 1997. Regulation: 8.