
Axialtome Corp.
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AXIAL TOME, 60, FLUORO AND TOMAX is an FDA 510(k)-cleared medical device (K872825) manufactured by Axialtome 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 March 30, 1988. Regulation: 8.