# K253036: Light-curing Coloring Materials (ALCM)

- Pathway: 510(k) (Traditional)
- Applicant: Aidite (Qinhuangdao) Technology Co., Ltd.
- Decided: Apr 6, 2026 after 196 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: 1 generation back to K121230 (2012). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121230: Ips Empress Direct Color Ips Empress Direct Opaque, Ivoclar Vivadent, AG (2012) Summary page 5.

## Indications for use
This product is used for the individualized staining of directly placed and laboratory-fabricated acrylic resin restorations, composite resin restorations, and resin-based ceramics

Source page: https://510kreport.com/device/K253036
Methodology: https://510kreport.com/methodology