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Biomet 3i, Inc.
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BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS is an FDA 510(k)-cleared medical device (K101608) manufactured by Biomet 3i, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 10, 2011. Regulation: 8.