# K201038: Luce Ceramic Bracket

- Pathway: 510(k) (Traditional)
- Applicant: Luce Castle Co., Ltd.
- Decided: Oct 9, 2020 after 172 days
- Product code: NJM (Bracket, Ceramic, Orthodontic)
- 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: 2 generations back to K073045 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163117: Alpha Pure, Koroad America (2017) Summary page 4.

## Indications for use
This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only

Source page: https://510kreport.com/device/K201038
Methodology: https://510kreport.com/methodology