# K183643: Clear Image Aligners

- Pathway: 510(k) (Traditional)
- Applicant: Specialty Appliance Works, Inc.
- Decided: Jan 3, 2019 after 8 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). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173785: Custom Clear Aligner System, Derby Dental Laboratory (2018) Summary page 4.

## Most influential descendants
- K192470: DenMat Orthodontic Aligners (2019), 0 descendants of its own

## Indications for use
The Clear Image Aligners are indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion,

Source page: https://510kreport.com/device/K183643
Methodology: https://510kreport.com/methodology