# K111185: Relyx Luting Plus Automix

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe Dental Products
- Decided: May 5, 2011 after 8 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: 2 generations back to K933139 (1994). 3 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022476: Relyx Rmgip, 3M Company (2002) Summary page 1.

## Most influential descendants
- K123265: Rmgi Low Viscosity (2012), 5 descendants of its own
- K130223: Rmgi Fill (2013), 4 descendants of its own
- K153249: Pulpdent Solo Flowable Composite with MCP (2016), 1 descendant of its own
- K250953: Equia LC One (2025), 0 descendants of its own
- K250566: EsCem RMGI (2025), 0 descendants of its own

## Indications for use
This device is intended for use as a dental cement. RelyX TM Luting Plus Automix (Lexus-2) is indicated for Luting: * Lutiing porcelain fused to metal crowns and bridges to tooth structure, amalgam, composite or glass janomer core build ups; * Luting metal inlays, onlays or crowns; * Luting pre-fabricated and cast post cementation * Luting orthodontic appliances * Luting crowns made with all-alumina or all zirconia cores such as Procerag AlICeram

Source page: https://510kreport.com/device/K111185
Methodology: https://510kreport.com/methodology