# K990534: Excite

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar North America, Inc.
- Decided: Mar 19, 1999 after 28 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Excite adhesive is for use in clinical situations in which adhesion between light initiated resin based restorative or cementation materials and dentin and enamel is desired. Adhesion of direct light initiated resin based restorations or repairs including: composite, ceromer and compomer to enamel and dentin. Adhesion of light initiated resin based cementation materials to enamel and dentin during final placement of indirect restorations including: veneers, inlays, onlays, and single and multiple unit restorations. As a resin based wetting agent to improve adhesion between silanated ceramic or ceromer surfaces (indirect restorations, repairs) and light initiated resin cements and restoratives.

Source page: https://510kreport.com/device/K990534
Methodology: https://510kreport.com/methodology