# K211537: QuickAligners

- Pathway: 510(k) (Traditional)
- Applicant: Oral Image, Inc.
- Decided: Oct 26, 2021 after 161 days
- Product code: NXC (Aligner, Sequential)
- 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: 6 generations back to K780619 (1978). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202857: ClearPath Aligner, Clearpath Orthodontics, Ltd. (2021) Summary page 4.

## Indications for use
Oral Image QuickAligners are indicated for the alignment of teeth in patients with permanent dentition (i.e. all second molars) during orthodontic treatment of malocclusion. QuickAligners position teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K211537
Methodology: https://510kreport.com/methodology