FDA-Device2014-09-17Class II
BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.
Biomet 3i, LLC
Hazard
Identifiers on the label are correct but the label has the incorrect color coding.
Sold states
US Distribution to NH and TX.
Affected count
6 units
Manufactured in
4555 Riverside Dr, N/A, Palm Beach Gardens, FL, United States
Products
BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2594-2014Don't want to check this manually?
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