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Owandy Sas
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UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE) is an FDA 510(k)-cleared medical device (K053172) manufactured by Owandy Sas. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 8, 2006. Regulation: 8.