# K942826: Orthodonitc Metal Reinforced Plastic Bracket

- Pathway: 510(k) (Traditional)
- Applicant: Gac Intl., Inc.
- Decided: Dec 14, 1994 after 183 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K092030: Elation MB Metal Reinforced Plastic Bracket (2009), 4 descendants of its own
- K140807: Composite Orthodontic Brackets (2014), 2 descendants of its own
- K201940: Braces on Demand Bracket (2020), 0 descendants of its own
- K180718: Orthodontic Plastic Brackets and Accessories (2018), 0 descendants of its own
- K150830: CompleClear Plastic Orthodontic Bracket and Wire Appliance (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K942826
Methodology: https://510kreport.com/methodology