# K100301: Opal Bond Flow

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Apr 29, 2010 after 85 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 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)
- K073697: Transbond Supreme Adhesive, 3M Unitek (2008) Summary page 1.
- K083051: Flowtain & Flowtain LV, Reliance Orthodontic Products, Inc. (2009) Summary page 2.

## Indications for use
Opal® BondTm Flow is a light viscosity, light cure bonding adhesive used for bonding to etched enamel and is recommended for appliances, permanent retainers, bondable bite turbos/ramps or similar applications.

Source page: https://510kreport.com/device/K100301
Methodology: https://510kreport.com/methodology