# K053379: Reli-on One Step, Orthodontic Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Classone Orthodontics, Inc.
- Decided: Jan 25, 2006 after 51 days
- Product code: DYH (Adhesive, Bracket And Tooth Conditioner, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3750
- 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. The FDA summary names its predicate without a number.
- (no number) Right-On Adhesive bonding system: named in the summary without a submission number

## Indications for use
This device is intended for bonding brackets to teeth for orthodontic treatment.

Source page: https://510kreport.com/device/K053379
Methodology: https://510kreport.com/methodology