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KLS-Martin L.P.
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TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION is an FDA 510(k)-cleared medical device (K002152) manufactured by KLS-Martin L.P.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 9, 2000. Regulation: 8.