# K962946: Ortho-One

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Sep 3, 1996 after 36 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
Longest line of descent: 1 generation back to K875143 (1988). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K875143: Rely-a-Bond (NO Mix Orthodontic Adhesive), Reliance Orthodontic Products, Inc. (1988) Summary page 1.

## Most influential descendants
- K113401: Ortho-1(Not Finalized) (2012), 0 descendants of its own

## Indications for use
ORTHO-ONE is indicated for the adhesion of orthodontic brackets to acid etched enamel.

Source page: https://510kreport.com/device/K962946
Methodology: https://510kreport.com/methodology