# K251415: Additively Manufactured Aligner Resin

- Pathway: 510(k) (Traditional)
- Applicant: Aidite (Qinhuangdao) Technology Co., Ltd.
- Decided: Aug 27, 2025 after 112 days
- Product code: NXC (Aligner, Sequential)
- Device class: 2
- Regulation: 21 CFR 872.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K780619 (1978). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212680: LuxCreo Clear Aligner System, LuxCreo, Inc. (2022) Summary page 6.
- K221022: NextDent Ortho Flex, Vertex-Dental B.V. (2022) Summary page 6.

## Indications for use
This product is suitable for making invisible orthodontic appliances by additive manufacturing (light curing 3D printing) process. The orthodontic appliance is designed for orthodontic treatment. It uses continuous gentle force to adjust tooth position, correct malocclusion, and maintain the results of completed orthodontic treatment. It can also be used for printing splints and night guards.

Source page: https://510kreport.com/device/K251415
Methodology: https://510kreport.com/methodology