# K123595: Nexus Rmgi

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Corporation
- Decided: Feb 19, 2013 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: 3 generations back to K933139 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111185: Relyx Luting Plus Automix, 3M Espe Dental Products (2011) Summary page 1.

## Indications for use
Nexus RMGI is intended for use as a permanent dental cement. It is indicated for the following indirect restorations: 1. Cementation of metal-based inlays, onlays, crowns and bridges 2. Cementation of resin inlays, onlays, crowns and bridges 3. Cementation of all ceramic inlays 4. Cementation of high strength (zirconia based) all ceramic crowns and bridges 5. Cementation of metal, ceramic and fiber posts

Source page: https://510kreport.com/device/K123595
Methodology: https://510kreport.com/methodology