# K232011: Cleo

- Pathway: 510(k) (Traditional)
- Applicant: American Orthodontics
- Decided: Jul 7, 2023 after 1 day
- 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: 4 generations back to K852179 (1985). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122753: Empower Clear, American Orthodontics (2012) Summary page 4.
- K080749: Radiance, American Orthodontics (2008) Summary page 4.

## Indications for use
The Cleo bracket line is intended to operate together with other orthodontic devices to apply forces to teeth. Under the supervision of a trained dental professional or orthodontist, this may result in changes to the position of teeth. The Cleo bracket line is indicated for orthodontic treatment of malocclusions and craniofacial abnonnalities as diagnosed by a trained dental professional or orthodontist.

Source page: https://510kreport.com/device/K232011
Methodology: https://510kreport.com/methodology