FDA-Device2020-03-04Class II
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356
Biomet 3i, LLC
Hazard
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Sold states
Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
Affected count
N/A
Manufactured in
4555 Riverside Dr, N/A, Palm Beach Gardens, FL, United States
Products
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1371-2020Don't want to check this manually?
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