# K191548: Nexus Universal Self-Cure

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Corporation
- Decided: Oct 11, 2019 after 121 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K931812 (1993). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110508: Suglue-10, 3M Espe AG (2011) Summary page 5.

## Recalls of this device
- Feb 25, 2020 · Class II · Z-1824-2020: 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 fai

## Indications for use
Nexus Universal Self-Cure is a bonded resin cement indicated for the cementation of indirect restorations including veneers, inlays, onlays, crowns, bridges, posts, and the cementation of crown restorations to implant abutments. Nexus Universal Self-Cure can be used for the cementation of ceramic, porcelain, resin, metal-based, zirconia, and CAD/CAM block materials. Nexus Universal Self-Cure can also be used for the adhesive bonding of amalgam restorations and as a core build-up material.

Source page: https://510kreport.com/device/K191548
Methodology: https://510kreport.com/methodology