# K090355: Opal Seal

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Apr 29, 2009 after 77 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 K023042 (2002). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023042: PQ1, Ultradent Products, Inc. (2002) Summary page 1.

## Most influential descendants
- K242537: BracePaste Fluoride Sealant (2024), 0 descendants of its own
- K210115: FiteBac CC OrthoSeal (2021), 0 descendants of its own

## Indications for use
Opal® Seal is a light cure primer that is used when bonding orthodontic appliances to etched enamel.

Source page: https://510kreport.com/device/K090355
Methodology: https://510kreport.com/methodology