Blue Sky Bio CAD-CAM Abutments

Blue Sky Bio CAD-CAM Abutments is an FDA 510(k)-cleared medical device (K202026) 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 December 17, 2020. Regulation: 8.