# K094006: Opal Bond MV

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Mar 23, 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: 1 generation back to K071055 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071055: Opal Prime & Opal Bond/Orthodontic Bracket System, Models 2626, 2625, 2635, 2803, 2802, Ultradent Products, Inc. (2007) Summary page 1.

## Indications for use
Opal® Bond MV is a light cure orthodontic adhesive designed for bonding brackets and other bondable appliances to etched enamel.

Source page: https://510kreport.com/device/K094006
Methodology: https://510kreport.com/methodology