# K192470: DenMat Orthodontic Aligners

- Pathway: 510(k) (Traditional)
- Applicant: Denmat Holdings, LLC
- Decided: Dec 20, 2019 after 102 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: 7 generations back to K780619 (1978). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183643: Clear Image Aligners, Specialty Appliance Works, Inc. (2019) Summary page 4.

## Indications for use
The DenMat Orthodontic Aligners are indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.

Source page: https://510kreport.com/device/K192470
Methodology: https://510kreport.com/methodology