# K260170: LumiCera

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou SHINING3D Dental Technology Co., Ltd.
- Decided: Jan 21, 2026 after 1 day
- 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: 9 generations back to K042819 (2004). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 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 6.

## Indications for use
LumiCera is used for fabricating permanent single crowns, permanent inlays and onlays, veneers, bridges.

Source page: https://510kreport.com/device/K260170
Methodology: https://510kreport.com/methodology