FDA-Device2020-05-06Class II
Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The intended use of this device is to be used for the cementation of indirect restorations including veneers, inlays, onlays, bridges, posts, and the cementation of crown restorations to implant abutments.
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Hazard
An issue within production process used to package trial kits let to the inclusion of the incorrect bonding agent for the kit. Use of the incorrect bonding agent may lead to increased risk of bond failures.
Sold states
Worldwide distribution - US Nationwide distribution in the states of NV, TN, NY, WA, WI, GA, PA, TX, IN, FL, IL, IA, MD, CA, LA, , MI, AZ, NC, KY, SC and the country of Netherlands.
Affected count
111 kits
Manufactured in
1717 W Collins Ave, N/A, Orange, CA, United States
Products
Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The intended use of this device is to be used for the cementation of indirect restorations including veneers, inlays, onlays, bridges, posts, and the cementation of crown restorations to implant abutments.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1824-2020Don't want to check this manually?
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