# K121396: Dynaflex

- Pathway: 510(k) (Traditional)
- Applicant: Dyna Flex
- Decided: Aug 14, 2012 after 97 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: 4 generations back to K780619 (1978). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040874: Red, White & Blue, Allesee Orthodontic Appliances (2004) Summary page 1.
- K071970: Clear Image Aligner, Specialty Appliance Works, Inc. (2007) Summary page 1.
- K082556: Clearcorrect, Clearcorrect, Inc. (2009) Summary page 1.

## Indications for use
DynaFlex EZ-Align Appliance is a series of up to four, clear, lightweight, plastic retainers intended to be used to correct minor (1.5mm or less to inter canine/cusped crowding) anterior tooth misalignment in patients in permanent dentition by moving teeth progressively to a final, treated state. DynaFlex EZ-Align is for prescription only.

Source page: https://510kreport.com/device/K121396
Methodology: https://510kreport.com/methodology