IMAX 9.5 STERILIZERS

IMAX 9.5 STERILIZERS is an FDA 510(k)-cleared medical device (K052532) manufactured by Dental X Srl. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 4, 2006. Regulation: 8.