# K150830: CompleClear Plastic Orthodontic Bracket and Wire Appliance

- Pathway: 510(k) (Traditional)
- Applicant: Oracrew
- Decided: Aug 26, 2016 after 515 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: 6 generations back to K852179 (1985). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110796: Simpliclear Rectangular Orthodontic Wire, Biomers Products, LLC (2011) Summary page 6.
- K140807: Composite Orthodontic Brackets, Ortho Specialties (2014) Summary page 6.

## Indications for use
CompleClear appliances are intended for use as a clear, plastic bracket and archwire system to provide orthodontic movement of natural teeth.

Source page: https://510kreport.com/device/K150830
Methodology: https://510kreport.com/methodology