
Blue Sky Bio, LLC
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Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G is an FDA 510(k)-cleared medical device (K221845) manufactured by Blue Sky Bio, 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 February 23, 2023. Regulation: 8.