# K090567: Orthodontic Ceramic Bracket

- Pathway: 510(k) (Traditional)
- Applicant: Star Dentech Korea., Corp
- Decided: May 27, 2009 after 85 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.
2 later devices descend from it; 2 cite 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)
- K073045: Sapphire Ceramic Bracket, Ortho Technology, Inc. (2007) Summary page 1.

## Most influential descendants
- K102561: Orthodontic Ceramic Bracket (2011), 0 descendants of its own
- K101481: Biomers Translucent Orthodontic Bracket (2010), 0 descendants of its own

## Indications for use
Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth

Source page: https://510kreport.com/device/K090567
Methodology: https://510kreport.com/methodology