# K053055: Orthodontic Polymer Composite Bracket

- Pathway: 510(k) (Traditional)
- Applicant: Gestenco International AB
- Decided: Dec 22, 2005 after 52 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K180718: Orthodontic Plastic Brackets and Accessories (2018), 0 descendants of its own

## Indications for use
Orthodontic Polymer Composite Bracket is intended to be bonded on teeth to aid in the movement of patient's teeth during orthodontic treatment.

Source page: https://510kreport.com/device/K053055
Methodology: https://510kreport.com/methodology