# K171844: Inspire ICE aka Inspire ICE Clear Brackets

- Pathway: 510(k) (Traditional)
- Applicant: Ormco Corporation
- Decided: Jul 18, 2017 after 28 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 K080749 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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 5.

## Indications for use
Inspire ICE, a ceramic orthodontic bracket, is intended for use during orthodontic treatment of malocclusions. A malocclusion is imperfect positioning of the teeth when the jaws are closed.

Source page: https://510kreport.com/device/K171844
Methodology: https://510kreport.com/methodology