# K081143: Biomers Translucent Orthodontic Wire

- Pathway: 510(k) (Traditional)
- Applicant: Biomers Product, LLC
- Decided: May 2, 2008 after 10 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: 1 generation back to K894781 (1989). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894781: Optiflex, Ormco Corp. (1989) Summary page 1.
- (no number) Super Elastic Nickel Titanium Arch Wire: named in the summary without a submission number

## Most influential descendants
- K110796: Simpliclear Rectangular Orthodontic Wire (2011), 1 descendant of its own
- K150830: CompleClear Plastic Orthodontic Bracket and Wire Appliance (2016), 0 descendants of its own

## Indications for use
An orthodontic arch wire used to provide force to the teeth to effect movement in the early (leveling and aligning) stage of orthodontic treatment.

Source page: https://510kreport.com/device/K081143
Methodology: https://510kreport.com/methodology