# K101676: Cleararch

- Pathway: 510(k) (Traditional)
- Applicant: Ormco Corp.
- Decided: Sep 13, 2010 after 90 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.
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) BioMers Translucent Orthodontic Wire: named in the summary without a submission number

## Indications for use
The ClearArch is indicated for use as an orthodontic arch wire to aid in the movement of patient teeth during orthodontic treatment. ClearArch is intended for patients seeking esthetic orthodontic treatment; these are primarily patients being treated with ceramic or polycarbonate braces.

Source page: https://510kreport.com/device/K101676
Methodology: https://510kreport.com/methodology