# K112640: Hyperelastic Wire

- Pathway: 510(k) (Traditional)
- Applicant: Ormco Corp.
- Decided: Nov 16, 2011 after 65 days
- Product code: DZC (Wire, Orthodontic)
- Device class: 1
- Regulation: 21 CFR 872.5410
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CuTiNi Wire: named in the summary without a submission number

## Indications for use
The Hyperelastic Archwire is indicated for use as an orthodontic arch wire to aid in the movement of teeth during the early phase of orthodontic treatment. The Hyperelastic Archwire may be used in conjunction with metallic, ceramic, or plastic brackets.

Source page: https://510kreport.com/device/K112640
Methodology: https://510kreport.com/methodology