# K190583: DynaFlex

- Pathway: 510(k) (Traditional)
- Applicant: Dyna Flex
- Decided: Jun 27, 2019 after 113 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: 3 generations back to K780619 (1978). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071970: Clear Image Aligner, Specialty Appliance Works, Inc. (2007) Summary page 4.

## Indications for use
DynaFlex® Clear Aligner is a series of clear, lightweight, plastic retainers indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion in patients by moving teeth progressively to a final, treated state.

Source page: https://510kreport.com/device/K190583
Methodology: https://510kreport.com/methodology