# K180952: Ceramic Bracket

- Pathway: 510(k) (Traditional)
- Applicant: Mem Dental Technology Co., Ltd.
- Decided: Jun 7, 2019 after 422 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: 5 generations back to K852179 (1985). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160615: Orthodontic Ceramic Brackets 1.1, Tomy, Inc. (2016) Summary page 4.

## Indications for use
Ceramic Bracket is indicated for orthodontic movement of natural teeth.

Source page: https://510kreport.com/device/K180952
Methodology: https://510kreport.com/methodology