510(k) · Cleared
Recalled · Class II · 2013Excite F and Excite DSC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Mar 10, 2010 after a 96-day review. The FDA summary names no predicate by number. It has been recalled once.
- Decided
- Mar 10, 2010
- Review
- 96 days
- Class
- Class II
- Product code
- KLE
- Recalls
- 1
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KLE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KLE device
- #1 K262252 MPa Max adhesivescore 15.1 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 23, 2013 | Class II | Z-0376-2014 | Material/Component Contamination | 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. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KLE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KLE
149in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KLE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLE
3in 2025
MAUDE reports naming product code KLE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 71 | 2 | 18 |
| 2008 | 3 | 66 | 0 | 9 |
| 2009 | 7 | 79 | 1 | 11 |
| 2010 | 8 | 93 | 1 | 13 |
| 2011 | 10 | 100 | 0 | 69 |
| 2012 | 5 | 66 | 0 | 176 |
| 2013 | 11 | 115 | 0 | 248 |
| 2014 | 6 | 120 | 0 | 260 |
| 2015 | 10 | 118 | 0 | 100 |
| 2016 | 3 | 148 | 1 | 47 |
| 2017 | 4 | 171 | 1 | 42 |
| 2018 | 8 | 124 | 0 | 31 |
| 2019 | 6 | 143 | 0 | 20 |
| 2020 | 6 | 195 | 0 | 6 |
| 2021 | 4 | 163 | 0 | 6 |
| 2022 | 8 | 98 | 0 | 7 |
| 2023 | 6 | 75 | 0 | 7 |
| 2024 | 7 | 61 | 1 | 12 |
| 2025 | 3 | 149 | 0 | 3 |
| 2026 | 7 | 84 | 0 | — |
What is it indicated for?
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…
Read the full statement (120 words)
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)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093744 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093744: Excite F and Excite DSC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093744
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026