
Biomet 3i
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Eztetic BellaTek Encode Healing Abutments is an FDA 510(k)-cleared medical device (K170013) 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 September 20, 2017. Regulation: 8.