# K250497: Additive Manufacturing (Light Curing) Crown Bridge Resin

- Pathway: 510(k) (Traditional)
- Applicant: Aidite (Qinhuangdao) Technology Co., Ltd.
- Decided: Apr 30, 2025 after 69 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: 10 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)
- K222877: FREEPRINT crown, Detax GmbH (2022) Summary page 5.
- K233596: VarseoSmile TriniQ, Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG (2023) Summary page 6.

## Indications for use
Additive Manufacturing (Light Curing) Crown Bridge Resin is a light-cured resin indicated for the fabrication of permanent single crowns in the anterior and posterior region, denture teeth, inlays, onlays, veneers and implant crown. It is also used for long-term provisional crowns and bridges.

Source page: https://510kreport.com/device/K250497
Methodology: https://510kreport.com/methodology