# K250763: Reon

- Pathway: 510(k) (Traditional)
- Applicant: C.E.I.B.Med
- Decided: May 12, 2025 after 60 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: 9 generations back to K042819 (2004). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233502: Tera Harz II, Graphy, Inc. (2023) Summary page 7.

## Indications for use
Reon is a 3D printing resin used in dentistry for the fabrication of both temporary and permanent dental restorations, specifically crowns, bridges, inlays, onlays, and veneers.

Source page: https://510kreport.com/device/K250763
Methodology: https://510kreport.com/methodology