openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 5
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
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Lot Numbers/UDI: 8442784-1/(01)00844868031130(10)8442784-1, 8442469-1/(01)00844868031130(10)8442469-1, 8442689-1/(01)00844868031130(10)8442689-1
Distribution pattern
Nationwide and Puerto Rico, Canada, and Australia
device · product 2 of 5
CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
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.
These labels are deterministic app interpretations, not FDA categories.
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.
CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Lot Numbers/UDI: 8441907-1/(01)00844868031284(10)8441907-1 8441907-2/(01)00844868031284(10)8441907-2 8441907-3/(01)00844868031284(10)8441907-3 8442367-1/(01)00844868031284(10)8442367-1 8439134A-3/(01)00844868031284(10)8439134A-3 8439134A-4/(01)00844868031284(10)8439134A-4
Distribution pattern
Nationwide and Puerto Rico, Canada, and Australia
device · product 4 of 5
CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Lot Numbers/UDI: 8442561-2/(01)00844868031352(10)8442561-2 8442561-3/(01)00844868031352(10)8442561-3
Distribution pattern
Nationwide and Puerto Rico, Canada, and Australia
device · product 5 of 5
CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - Product Usage:BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
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.
These labels are deterministic app interpretations, not FDA categories.
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.
