FDA-Device2025-09-10Class II
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Preat Corp
Hazard
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.
Sold states
US Nationwide distribution in the states of NY, FL, PA, CA, OH.
Affected count
11
Manufactured in
2625 Skyway Dr Ste B, N/A, Santa Maria, CA, United States
Products
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2514-2025Don't want to check this manually?
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