# K080749: Radiance

- Pathway: 510(k) (Traditional)
- Applicant: American Orthodontics
- Decided: Aug 4, 2008 after 140 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.
4 later devices descend from it; 4 cite it directly.
0 of 5 devices 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.

## Most influential descendants
- K122753: Empower Clear (2012), 1 descendant of its own
- K232011: Cleo (2023), 0 descendants of its own
- K171844: Inspire ICE aka Inspire ICE Clear Brackets (2017), 0 descendants of its own
- K142729: Chi Lites Orthodontic Sapphire Bracket (2015), 0 descendants of its own

## Indications for use
Radiance is an orthodontic bracket. Orthodontic brackets are prescribed for patients with teeth that are not normally positioned in the mouth. An orthodontic bracket is a device consisting of a base, an arch wire slot and four tie wings. The bracket bases are attached to a patient's teeth with adhesive. A metal arch wire is placed in the arch wire slot of a set of brackets (typi.cally ten brackets on each of the upper and lower arches) and the wire is held in place in each bracket slot with an elastic o-ring placed under the tie winfi';. and over the arch wire. Orthodontic treatment is used to correct dental deficiencies and to improve the appearance of the patient. The brackets, arch wire and elastic o-riings form a force system that is designed to gradually move teeth into a normal alignment. Radiance brackets can enhance the patient's appearance during treatment because the bracket is highly transparent. These brackets are less visible than metal brackets and are preferred hy many patients - especially adults.

Source page: https://510kreport.com/device/K080749
Methodology: https://510kreport.com/methodology