
Villa Sistemi Medicali S.P.A.
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STRATO X is an FDA 510(k)-cleared medical device (K002432) manufactured by Villa Sistemi Medicali S.P.A.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 31, 2000. Regulation: 8.