# K182672: ROSA Bracket

- Pathway: 510(k) (Traditional)
- Applicant: Gni Co., Ltd.
- Decided: Nov 15, 2019 after 415 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.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150141: Orthodontics Bracket, Speed Dental Co., Ltd. (2015) Summary page 5.

## Most influential descendants
- K201410: VENUS Bracket, ROSE Bracket (2021), 0 descendants of its own

## 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/K182672
Methodology: https://510kreport.com/methodology