# K151332: Nexus Universal, Nexus Universal Chroma

- Pathway: 510(k) (Abbreviated)
- Applicant: Sybron Dental Specialties
- Decided: Aug 17, 2015 after 90 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K073209 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073209: Maxcem 2, Kerr Corporation (2008) Summary page 4.

## Indications for use
Nexus Universal/Nexus Universal Chroma is indicated for cementation of all indirect restorations including ceramic, resin, and metal-based inlays/onlays, crowns, bridges, posts, and veneers*. Additional indications include core build-ups and cementation of crowns to implants. *Adhesive application on the preparation is required for veneer cementation using Nexus Universal and Nexus Universal Chroma.

Source page: https://510kreport.com/device/K151332
Methodology: https://510kreport.com/methodology