# K071055: Opal Prime & Opal Bond/Orthodontic Bracket System, Models 2626, 2625, 2635, 2803, 2802

- Pathway: 510(k) (Special)
- Applicant: Ultradent Products, Inc.
- Decided: May 3, 2007 after 17 days
- Product code: DYW (Bracket, Plastic, Orthodontic)
- Device class: 2
- Regulation: 21 CFR 872.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Orthodontic Composite Bracket System: named in the summary without a submission number

## Most influential descendants
- K094006: Opal Bond MV (2010), 0 descendants of its own

## Indications for use
The Orthodontic Composite Bracket System is a self-ligating orthodontic bracket uniquely formed in a one piece unit and includes an Adhesive Paste and Adhesive Primer. This system is a bondable device for fixed attached orthodontics.

Source page: https://510kreport.com/device/K071055
Methodology: https://510kreport.com/methodology