# K073045: Sapphire Ceramic Bracket

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Technology, Inc.
- Decided: Dec 18, 2007 after 50 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
No predicates in its family tree.
10 later devices descend from it; 7 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K150141: Orthodontics Bracket (2015), 2 descendants of its own
- K090567: Orthodontic Ceramic Bracket (2009), 2 descendants of its own
- K182672: ROSA Bracket (2019), 1 descendant of its own
- K163117: Alpha Pure (2017), 1 descendant of its own
- K201410: VENUS Bracket, ROSE Bracket (2021), 0 descendants of its own

Source page: https://510kreport.com/device/K073045
Methodology: https://510kreport.com/methodology