# K980053: Glenroe Chain

- Pathway: 510(k) (Traditional)
- Applicant: Glenroe Technologies
- Decided: Feb 24, 1998 after 49 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
Used to connect brackets and help to close space between teeth. They are normally used for a period of 4 to 6 weeks, then replaced with new chain.

Source page: https://510kreport.com/device/K980053
Methodology: https://510kreport.com/methodology