# K122753: Empower Clear

- Pathway: 510(k) (Traditional)
- Applicant: American Orthodontics
- Decided: Dec 14, 2012 after 98 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: 3 generations back to K852179 (1985). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080749: Radiance, American Orthodontics (2008) Summary page 1.
- K060837: IN-Ovation C, Dentsply International (2006) Summary page 1.

## Most influential descendants
- K232011: Cleo (2023), 0 descendants of its own

## Indications for use
Empower Clear brackets are intended for orthodontic movement of teeth as diagnosed by an orthodontist. It is used temporarily and is removed upon completion of orthodontic treatment. Empower Clear brackets are intended to be single use only.

Source page: https://510kreport.com/device/K122753
Methodology: https://510kreport.com/methodology