# K151541: G-Fix

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Oct 9, 2015 after 123 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: 1 generation back to K020342 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020342: Unifil Flow, GC America, Inc. (2002) Summary page 4.

## Indications for use
Splinting mobile teeth

Source page: https://510kreport.com/device/K151541
Methodology: https://510kreport.com/methodology