510(k) · Cleared
ClearedModification to Prompt L-Pop
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espe Dental AG · KLE Agent, Tooth Bonding, Resin
Cleared on Jul 7, 2000 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 44 later devices descend from it.
- Decided
- Jul 7, 2000
- Review
- 56 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 0
44 later devices descend from it, 3 citing it directly.
- This deviceK001494 Modification to Prompt L-PopEspe Dental AG · 2000
- Descendant · cites it directly · 42 of its ownK020946 Adper Prompt3M Espe AG Dental Products · 2002
- Descendant · 2 generations on · 39 of its ownK040857 Modification to Adper Prompt3M Espe AG Dental Products · 2004
- Descendant · 3 generations on · 38 of its ownK060684 Adper Prompt, Adper Prompt L-Pop3M Espe AG Dental Products · 2006
- Descendant · 2 generations on · 37 of its ownK043043 Hermes Bond 23M Espe AG Dental Products · 2005
- Descendant · cites it directly · 35 of its ownK071131 UNO3M Espe AG Dental Products · 2007
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K020946Adper Prompt3M Espe AG Dental Products · 2002 · cites it directly42descendants
- K040857Modification to Adper Prompt3M Espe AG Dental Products · 2004 · 2 generations on39descendants
- K060684Adper Prompt, Adper Prompt L-Pop3M Espe AG Dental Products · 2006 · 3 generations on38descendants
- K043043Hermes Bond 23M Espe AG Dental Products · 2005 · 2 generations on37descendants
- K071131UNO3M Espe AG Dental Products · 2007 · cites it directly35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001494 | Modification to Prompt L-Pop | Espe Dental AG | 2000 | — |
| +1 | K020946 | Adper Prompt | 3M Espe AG Dental Products | 2002 | — |
| +2 | K040857 | Modification to Adper Prompt | 3M Espe AG Dental Products | 2004 | — |
| +3 | K060684 | Adper Prompt, Adper Prompt L-Pop | 3M Espe AG Dental Products | 2006 | — |
| +2 | K043043 | Hermes Bond 2 | 3M Espe AG Dental Products | 2005 | — |
| +1 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 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? (44)
See all 443 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, K020946 (3M Espe AG Dental Products, 2002) has gone furthest, with 42 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/K001494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001494: Modification to Prompt L-Pop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001494
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026