TSV BellaTek Encode Healing Abutments

TSV BellaTek Encode Healing Abutments is an FDA 510(k)-cleared medical device (K173374) 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 December 12, 2017. Regulation: 8.