
Rapid Injection Systems Corp.
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FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD is an FDA 510(k)-cleared medical device (K072479) manufactured by Rapid Injection Systems 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 November 8, 2007. Regulation: 8.