# K973776: Reflections

- Pathway: 510(k) (Traditional)
- Applicant: Cdb Corp.
- Decided: Nov 21, 1997 after 49 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.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K140807: Composite Orthodontic Brackets (2014), 2 descendants of its own
- K113334: Avex CX2  and Avex CXI2 Ceramic Brackets (2012), 1 descendant of its own
- K251196: Composite Orthodontic Brackets and Buttons (2025), 0 descendants of its own
- 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
Orthodontic brackets are usually cemented to the front surface of the tooth where they direct the mechanical forces that urge teeth into correct alignment. A curved arch wire that is bent or twisted to a particular prescription before installation is forced into a slot in each bracket. The resulting torque or restoring force causes the teeth to shift into the desired alignment. Depending on the shape and twist of the arch wire and the orientation of the bracket slot, it is possible to apply forces, which can shift, rotate, or tip the teeth in any desired direction. Stainless steel, ceramic and plastic brackets are in common use. Plastic brackets are more aesthetically pleasing than the stainless steet which give a metallic smile. They are less expensive than ceramic.

Source page: https://510kreport.com/device/K973776
Methodology: https://510kreport.com/methodology