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Dentall Corp.
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SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L is an FDA 510(k)-cleared medical device (K061658) manufactured by Dentall 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 September 17, 2006. Regulation: 8.