ELATION MB METAL REINFORCED PLASTIC BRACKET

ELATION MB METAL REINFORCED PLASTIC BRACKET is an FDA 510(k)-cleared medical device (K092030) manufactured by Dentsply Interntional. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 23, 2009. Regulation: 8.