# K192260: everX Flow

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Nov 22, 2019 after 93 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K041474 (2004). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153127: everX Posterior, GC America, Inc. (2016) Summary page 4.

## Indications for use
everX Flow is a reinforcing dentin replacement material suitable for: 1. All direct composite restorations including large posterior cavities. 2. Deep cavities and endo-treated teeth. 3. Cavities with missing cusps or after amalgam removal and cavities where inlays and onlays would also be recommended. 4. Core build-up

Source page: https://510kreport.com/device/K192260
Methodology: https://510kreport.com/methodology