
3M Company, Unitek Orthodontic Products
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3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) is an FDA 510(k)-cleared medical device (K211190) manufactured by 3M Company, Unitek Orthodontic Products. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 22, 2021. Regulation: 8.