# K113401: Ortho-1(Not Finalized)

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Feb 7, 2012 after 82 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: 2 generations back to K875143 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962946: Ortho-One, Bisco, Inc. (1996) Summary page 1.
- K001048: Light Bond (Quick Cure), Reliance Orthodontic Products, Inc. (2000) Summary page 1.
- K101485: All-Etch, All- Etch with Bac; Uni- Etch, Uni- Etch with Bac; Etch- 37, Etch- 37 with Bac; Dark- Etch, Dark Etch (Blue- E, Bisco, Inc. (2010) Summary page 1.

## Indications for use
The indication for use of Ortho-1 is a bracket bonding system in the oral cavity of dental patients.

Source page: https://510kreport.com/device/K113401
Methodology: https://510kreport.com/methodology