
Tuxedo Imaging, LLC
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TuxDeluxe (Size 1 6100B, Size 2 6101B) is an FDA 510(k)-cleared medical device (K232552) manufactured by Tuxedo Imaging, LLC. 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 19, 2023. Regulation: 8.