# K261261: Dura-Arch

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou SHINING3D Dental Technology Co., Ltd.
- Decided: Apr 17, 2026 after 1 day
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K070991 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201827: GR-17 Resin System, Pro3Dure Medical GmbH (2020) Summary page 6.

## Indications for use
The product is indicated for the fabrication, by additive manufacturing, of temporary dental restorations, and preformed denture teeth to be used in a denture.

Source page: https://510kreport.com/device/K261261
Methodology: https://510kreport.com/methodology