# K191122: 3M RelyX Pediatric Resin Modified Glass Ionomer Cement

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe Dental Products
- Decided: May 29, 2019 after 30 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 4.
- K001730: GC Fujicem, GC America, Inc. (2000) Summary page 4.

## Indications for use
Permanent cementation of pediatric crowns: • Stainless Steel Crowns • Zirconia Crowns • 3MTM Pediatric Esthetic Crowns

Source page: https://510kreport.com/device/K191122
Methodology: https://510kreport.com/methodology