# K112707: Generation C Aesthetic Self-Ligating Bracket System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Technology, Inc.
- Decided: Jan 13, 2012 after 116 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Generation CT Aesthetic Self-Ligating Bracket System indication for use is to correct malocclusions of the teeth as determined by a licensed Orthodontist/Dentist. The brackets are intended to only be bonded to natural teeth. The brackets are used with orthodontic wire to control the direction of the tooth movement of the individual teeth by providing a slow and continuous force to the teeth.

Source page: https://510kreport.com/device/K112707
Methodology: https://510kreport.com/methodology