# K111876: Z Bond, Prelude One

- Pathway: 510(k) (Traditional)
- Applicant: Danville Materials, Inc.
- Decided: Sep 21, 2011 after 82 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 no predicate by number.

## Indications for use
Z Bond and Prelude One are a Primer and adhesive used for: Conditioning of zirconia, alumina, and metal definitive restorations prior to cementation, e.g., crowns, posts, inlays, and onlays. Adhesive repair of defects in zirconia, alumina, metal and composite restorations currently affixed to a patient's dentition. Adhesive for bonding composites and other dental restorative materials to enamel or dentin.

Source page: https://510kreport.com/device/K111876
Methodology: https://510kreport.com/methodology