FDA-Device2019-08-14Class II
CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
Biomet 3i, LLC
Hazard
During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Sold states
Nationwide and Puerto Rico, Canada, and Australia
Affected count
3 units
Manufactured in
4555 Riverside Dr, N/A, Palm Beach Gardens, FL, United States
Products
CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2140-2019Don't want to check this manually?
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