# K250566: EsCem RMGI

- Pathway: 510(k) (Traditional)
- Applicant: Spident Co., Ltd.
- Decided: Jun 20, 2025 after 114 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 5.

## Indications for use
Final cementation of - Metal inlays, onlays, crowns and bridges - Resin inlays, onlays, crowns and bridges - Ceramic inlays - Zirconia crowns and bridges - Metal, ceramic and fiber posts

Source page: https://510kreport.com/device/K250566
Methodology: https://510kreport.com/methodology