
Ivoclar North America, Inc.
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SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) is an FDA 510(k)-cleared medical device (K003407) manufactured by Ivoclar North America, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 25, 2001. Regulation: 8.