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Linvatec Corp.
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POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 is an FDA 510(k)-cleared medical device (K032607) manufactured by Linvatec 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 9, 2003. Regulation: 8.