# K972292: Solidex

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corp.
- Decided: Oct 29, 1997 after 132 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
No predicates in its family tree.
22 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K982164: Estenia (1998), 18 descendants of its own
- K012707: Estenia (2001), 17 descendants of its own
- K982259: Chroma Zone Color Stain (1998), 15 descendants of its own
- K012737: Chroma Zone Color Stain (2001), 14 descendants of its own
- K042929: Estenia C&B (2004), 12 descendants of its own

## Indications for use
Solidex is a light cured, hard crown and bridge composite. It is suitable for use in the construction of crowns and bridges, telescopic and cone crowns, attachment work, implant restoration, facings, jacket crowns, inlays and onlays, long-term provisionals, and veneers. It is universal product suitable for all classes of reconstructions, provided it is supported by adequate framework.

Source page: https://510kreport.com/device/K972292
Methodology: https://510kreport.com/methodology