# K090106: Prelude One

- Pathway: 510(k) (Traditional)
- Applicant: Danville Materials, Inc.
- Decided: Mar 31, 2009 after 89 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Clearfil S3: named in the summary without a submission number
- (no number) Xeno IV: named in the summary without a submission number

## Indications for use
Prelude One is a light cured adhesive designed for direct restorations, i.e. composites and compomers to enamel and/or dentin, composite repairs, porcelain repairs and post and core build-up materials, and indirect restorations such as veneers, onlays, inlays, crowns and bridges.

Source page: https://510kreport.com/device/K090106
Methodology: https://510kreport.com/methodology