# K190608: Mei Ceramic Bracket

- Pathway: 510(k) (Traditional)
- Applicant: Orthosun Co., Ltd.
- Decided: Nov 4, 2019 after 238 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: 1 generation back to K073045 (2007). 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)
- K073045: Sapphire Ceramic Bracket, Ortho Technology, Inc. (2007) Summary page 4.

## Indications for use
This Mei Ceramic Bracket 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/K190608
Methodology: https://510kreport.com/methodology