
Dental X-Ray E.U.
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ELITY 70 X-RAY is an FDA 510(k)-cleared medical device (K043136) manufactured by Dental X-Ray E.U.. 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 5, 2005. Regulation: 8.