# K140807: Composite Orthodontic Brackets

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Specialties
- Decided: Nov 12, 2014 after 225 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: 5 generations back to K852179 (1985). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092030: Elation MB Metal Reinforced Plastic Bracket, Dentsply Interntional (2009) Summary page 4.
- K973776: Reflections, Cdb Corp. (1997) Summary page 4.

## Most influential descendants
- K201940: Braces on Demand Bracket (2020), 0 descendants of its own
- K150830: CompleClear Plastic Orthodontic Bracket and Wire Appliance (2016), 0 descendants of its own

## Indications for use
The Composite Brackets are intended for use as a clear, plastic bracket system to provide orthodontic movement of natural teeth.

Source page: https://510kreport.com/device/K140807
Methodology: https://510kreport.com/methodology