# K251196: Composite Orthodontic Brackets and Buttons

- Pathway: 510(k) (Traditional)
- Applicant: Ec Certification Service GmbH
- Decided: Apr 21, 2025 after 4 days
- Product code: DYW (Bracket, Plastic, 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: 1 generation back to K973776 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973776: Reflections, Cdb Corp. (1997) Summary page 5.

## Indications for use
The intended use of composite brackets and buttons is to be bonded to the teeth to provide orthodontic movement of natural teeth. The main indication for use of orthodontic brackets and buttons is a malocclusion, such as misaligned teeth, overcrowding, spacing issues, and bite irregularities.

Source page: https://510kreport.com/device/K251196
Methodology: https://510kreport.com/methodology