# K894781: Optiflex

- Pathway: 510(k) (Traditional)
- Applicant: Ormco Corp.
- Decided: Sep 15, 1989 after 49 days
- Product code: EJF (Bracket, Metal, 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.
3 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K081143: Biomers Translucent Orthodontic Wire (2008), 2 descendants of its own
- 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

Source page: https://510kreport.com/device/K894781
Methodology: https://510kreport.com/methodology