
Gendex Dental Systems
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ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4 is an FDA 510(k)-cleared medical device (K050255) manufactured by Gendex Dental Systems. 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 16, 2005. Regulation: 8.