# K093744: Excite F and Excite DSC

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Mar 10, 2010 after 96 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Sep 23, 2013 · Class II · Z-0376-2014: Ivoclar Vivadent, Inc. is recalling a lot of ExciTE F DSC Dental Adhesive found to produce a blue green discoloration when used in combination with cements.

## Indications for use
Excite® F is a Light-curing, total etch, single component adhesive with fluoride release intended for use in clinical situations for: - Adhesive for direct light-curing and dual curing composite and compomner restorations - Adhesive for indirect all-ceramic and composite restorations (inlays, 6nMays, veneers; only light-curing) Excite® F DSC is a total etch, dual-curing and light curing adhesive with fluoride. release intended for use in clinical situations for: - Adhesive cementation of indirect, metal-free, translucent restorations (e.g. IPS Empress CAD, IPS Empress Esthetic) with dual or self curing luting composites (e.g. Variolink II) - direct restorations and core build ups with dual and self curing compositions (e.g. Multicore) - Direct restorations/cementation with light-curing composites (e.g. Tetric EvoCeram, Variolink II Base, Heliomolar)

Source page: https://510kreport.com/device/K093744
Methodology: https://510kreport.com/methodology