# K201940: Braces on Demand Bracket

- Pathway: 510(k) (Traditional)
- Applicant: Braces on Demand, Inc.
- Decided: Dec 3, 2020 after 143 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: 6 generations back to K852179 (1985). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140807: Composite Orthodontic Brackets, Ortho Specialties (2014) Summary page 4.
- K180941: Ortho System, 3Shape A/S (2018) Summary page 4.

## Indications for use
The Braces on Demand Bracket is intended for use as a clear, plastic bracket system to provide orthodontic movement of natural teeth.

Source page: https://510kreport.com/device/K201940
Methodology: https://510kreport.com/methodology