
Ivoclar Vivadent, Inc.
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ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050 is an FDA 510(k)-cleared medical device (K050453) manufactured by Ivoclar Vivadent, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 26, 2005. Regulation: 8.