Device product
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Z-2514-2025
Product summary
- Firm
- Preat Corp
- Event
- Event 97239
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11
- Official record key
device-enforcement:Z-2514-2025
Official wording
Reason: Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the abutment in the correct orientation, resulting in restoration delay.
Code information: UDI-DI: 00842092169599. Lot: 277097
Distribution pattern: US Nationwide distribution in the states of NY, FL, PA, CA, OH.
Derived failure modes
-
Unknown
Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the abutment in the correct orientation, resulting in restoration delay.