# K234043: 3M™ Transbond™ Orthodontic Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: 3M Unitek Orthodontic Products
- Decided: Dec 22, 2023 after 1 day
- 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 K030951 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083051: Flowtain & Flowtain LV, Reliance Orthodontic Products, Inc. (2009) Summary page 4.

## Indications for use
3M Transbond Orthodontic Adhesive is indicated for the following uses: * Creating attachments for orthodontic tray aligners. * Bonding orthodontic brackets to teeth.

Source page: https://510kreport.com/device/K234043
Methodology: https://510kreport.com/methodology