# K113334: Avex CX2  and Avex CXI2 Ceramic Brackets

- Pathway: 510(k) (Traditional)
- Applicant: Opal Orthodontics by Ultradent Products, Inc.
- Decided: Feb 3, 2012 after 81 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 K973776 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973776: Reflections, Cdb Corp. (1997) Summary page 1.

## Most influential descendants
- K152779: Avex CX2 (2015), 0 descendants of its own

## Indications for use
AVEX®I CX, and AVEX® CXi 2 Ceramic Brackets are intended for use in Orthodontic treatment.

Source page: https://510kreport.com/device/K113334
Methodology: https://510kreport.com/methodology