# K013584: Excite Self Etch

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Jan 28, 2002 after 90 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® Seff Etch is a light cured adhesive designed to bond composite and compomer to enamel and dentin. It is also an adhesive for light initiated resin cements used in conjunction with “transparent” indirect restorations, i.e. all ceramic (except zirconiumoxide) and composite restorations. Excite Self Etch is contraindicated for use as an adhesive with seif-curing resin cements Dual curing materials must be light initiated. This product is also contraindicated for zirconiumoxide ceramic restorations and for pulp capping.

Source page: https://510kreport.com/device/K013584
Methodology: https://510kreport.com/methodology