
Biomet 3i, LLC
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BellaTek Encode Emergence Healing Abutments is an FDA 510(k)-cleared medical device (K212730) 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 20, 2021. Regulation: 8.