# K152167: BIJOU Orthodontic Ceramic Bracket

- Pathway: 510(k) (Traditional)
- Applicant: World Bio Tech Co., Ltd.
- Decided: May 27, 2016 after 297 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
BIJOU Orthodontic Ceramic bracket is indicated for orthodontic movement of natural teeth.

Source page: https://510kreport.com/device/K152167
Methodology: https://510kreport.com/methodology