# K230225: DynaFlex Clear Brackets & Buttons

- Pathway: 510(k) (Traditional)
- Applicant: Dyna Flex
- Decided: Jun 5, 2023 after 129 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: 2 generations back to K081415 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173440: Carriere SLX 3D Clear, Ortho Organizers, Inc. (2018) Summary page 4.

## Indications for use
DynaFlex ® Clear Bracket & Buttons is indicated for alignment of teeth during orthodontic treatment.

Source page: https://510kreport.com/device/K230225
Methodology: https://510kreport.com/methodology