# K040952: Prelude

- Pathway: 510(k) (Traditional)
- Applicant: Danville Materials, Inc.
- Decided: Jun 29, 2004 after 78 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
Longest line of descent: 6 generations back to K931812 (1993). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990498: Optibond Solo Plus, Sybron Dental Specialties, Inc. (1999) Summary page 1.
- K014027: Optibond Solo Plus 4, Kerr Dental Materials Center (2002) Summary page 1.
- K990040: Clearfil SE Bond, Kuraray Co. (1999) Summary page 1.
- K012082: Optibond Solo Plus Activator, Sybron Dental Specialties, Inc. (2001) Summary page 1.

## Indications for use
Prelude 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. When used with Prelude Activator, Prelude may also be used with self or dual cure materials.

Source page: https://510kreport.com/device/K040952
Methodology: https://510kreport.com/methodology