# K152779: Avex CX2

- Pathway: 510(k) (Special)
- Applicant: Opal Orthodontics by Ultradent Products
- Decided: Nov 25, 2015 after 61 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: 2 generations back to K973776 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113334: Avex CX2  and Avex CXI2 Ceramic Brackets, Opal Orthodontics by Ultradent Products, Inc. (2012) Summary page 4.

## Indications for use
Avex® CX2 ceramic brackets are intended for use in orthodontic treatment.

Source page: https://510kreport.com/device/K152779
Methodology: https://510kreport.com/methodology