Certain BellaTek Express and BellaTek Flex Abutments

Certain BellaTek Express and BellaTek Flex Abutments is an FDA 510(k)-cleared medical device (K183138) manufactured by Biomet 3i. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 1, 2019. Regulation: 8.