TSV BellaTek Express and BellaTek Flex Abutments

TSV BellaTek Express and BellaTek Flex Abutments is an FDA 510(k)-cleared medical device (K192522) manufactured by Biomet 3i, 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 8, 2019. Regulation: 8.