510(k) · Cleared
ClearedEspe (R) -Sil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espe GmbH (Us) · KLE Agent, Tooth Bonding, Resin
Cleared on Dec 4, 1991 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 37 later devices descend from it.
- Decided
- Dec 4, 1991
- Review
- 90 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 0
37 later devices descend from it, 2 citing it directly.
- This deviceK913965 Espe (R) -SilEspe GmbH (Us) · 1991
- Descendant · cites it directly · 35 of its ownK071131 UNO3M Espe AG Dental Products · 2007
- Descendant · 2 generations on · 34 of its ownK110302 Adhesive Exl-7593M Espe AG · 2011
- Descendant · 3 generations on · 8 of its ownK112118 DreambondBisco, Inc. · 2011
- Descendant · 4 generations on · 6 of its ownK161051 All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016
- Descendant · 3 generations on · 5 of its ownK153231 G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc. · 2016
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K071131UNO3M Espe AG Dental Products · 2007 · cites it directly35descendants
- K110302Adhesive Exl-7593M Espe AG · 2011 · 2 generations on34descendants
- K112118DreambondBisco, Inc. · 2011 · 3 generations on8descendants
- K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016 · 4 generations on6descendants
- K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc. · 2016 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913965 | Espe (R) -Sil | Espe GmbH (Us) | 1991 | — |
| +1 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| +2 | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
| +3 | K112118 | Dreambond | Bisco, Inc. | 2011 | — |
| +4 | K161051 | All-Bond Universal w/BAC (not finalized) | Bisco, Inc. | 2016 | — |
| +3 | K153231 | G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer | GC America, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (37)
See all 372 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K071131 (3M Espe AG Dental Products, 2007) has gone furthest, with 35 descendants of its own.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K913965 · printed Nov 6, 2026
Cite this page
510(k) Report. “K913965: Espe (R) -Sil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913965
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026