# K980864: Power Coins Glow in the Dark Ligatures

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Kinetics Corp.
- Decided: Apr 20, 1998 after 46 days
- Product code: ECI (Band, Elastic, 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This device is intended to be used for the prescribed treatment of malocclusions by dentists. The device is used to hold the archwire in orthodontic brackets during orthodontic treatment. They are normally used for a period of 2 to 4 weeks when they are replaced.

Source page: https://510kreport.com/device/K980864
Methodology: https://510kreport.com/methodology