# K250953: Equia LC One

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Sep 19, 2025 after 175 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: 5 generations back to K933139 (1994). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130223: Rmgi Fill, Pulpdent Corporation (2013) Summary page 5.

## Indications for use
1. Class I, II, III, IV and V restorations 2. Root surface restoration 3. Core build-up

Source page: https://510kreport.com/device/K250953
Methodology: https://510kreport.com/methodology