# K180718: Orthodontic Plastic Brackets and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Tomy, Inc.
- Decided: Oct 30, 2018 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). 9 ancestors in all.
No later device cites it as a predicate yet.
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.
- K080906: CDB Clip, Cdb Corporation (2008) Summary page 4.
- K053055: Orthodontic Polymer Composite Bracket, Gestenco International AB (2005) Summary page 4.
- K042905: Neo-Clip Orthodontic Bracket Accessory, Dentsply Intl. (2004) Summary page 4.

## Indications for use
ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES are indicated for orthodontic movement of natural teeth.

Source page: https://510kreport.com/device/K180718
Methodology: https://510kreport.com/methodology