# K261356: Dura-Crown

- Pathway: 510(k) (Special)
- Applicant: Hangzhou SHINING3D Dental Technology Co., Ltd.
- Decided: Apr 27, 2026 after 3 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: 11 generations back to K042819 (2004). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K253053: Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1), Hangzhou SHINING3D Dental Technology Co., Ltd. (2025) Summary page 6.

## Indications for use
Dura-Crown is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. Dura-Crown is used for fabricating permanent restorations such as inlays, onlays, veneers, full crown and bridge restorations. Dura-Crown can also be used for the fabrication of artificial teeth and temporary crowns & bridges.

Source page: https://510kreport.com/device/K261356
Methodology: https://510kreport.com/methodology