510(k) · Cleared
ClearedAdper Prompt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Espe AG Dental Products · KLE Agent, Tooth Bonding, Resin
Cleared on Apr 4, 2002 as substantially equivalent to K001494 (Espe Dental AG, 2000) after a 10-day review. Its family tree reaches back 1 generation to 2000. 42 later devices descend from it.
- Decided
- Apr 4, 2002
- Review
- 10 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001494 (2000). 42 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK001494 Modification to Prompt L-PopEspe Dental AG · 2000
- This deviceK020946 Adper Prompt3M Espe AG Dental Products · 2002
- Descendant · cites it directly · 39 of its ownK040857 Modification to Adper Prompt3M Espe AG Dental Products · 2004
- Descendant · 2 generations on · 38 of its ownK060684 Adper Prompt, Adper Prompt L-Pop3M Espe AG Dental Products · 2006
- Descendant · cites it directly · 37 of its ownK043043 Hermes Bond 23M Espe AG Dental Products · 2005
- Descendant · 2 generations on · 35 of its ownK071131 UNO3M Espe AG Dental Products · 2007
- Descendant · 3 generations on · 34 of its ownK110302 Adhesive Exl-7593M Espe AG · 2011
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K040857Modification to Adper Prompt3M Espe AG Dental Products · 2004 · cites it directly39descendants
- K060684Adper Prompt, Adper Prompt L-Pop3M Espe AG Dental Products · 2006 · 2 generations on38descendants
- K043043Hermes Bond 23M Espe AG Dental Products · 2005 · cites it directly37descendants
- K071131UNO3M Espe AG Dental Products · 2007 · 2 generations on35descendants
- K110302Adhesive Exl-7593M Espe AG · 2011 · 3 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001494 | Modification to Prompt L-Pop | Espe Dental AG | 2000 | — |
| 0 (this device) | K020946 | Adper Prompt | 3M Espe AG Dental Products | 2002 | — |
| +1 | K040857 | Modification to Adper Prompt | 3M Espe AG Dental Products | 2004 | — |
| +2 | K060684 | Adper Prompt, Adper Prompt L-Pop | 3M Espe AG Dental Products | 2006 | — |
| +1 | K043043 | Hermes Bond 2 | 3M Espe AG Dental Products | 2005 | — |
| +2 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| +3 | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 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), 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K001494 | Modification to Prompt L-PopSummary page 1…mpt Classification Name:.......................... Resin Tooth Bonding Agent Common Name: ..........ccooociiiiiiiii, Dental Adhesive Predicate Device: Prompt L-Pop ... K 001494 Description for the Premarket Naotification Adper Prompt is classified as a Resin Tooth Bonding Agent (21 C.F.R. § 872.3200) be… | 2000 |
What descends from it? (42)
See all 424 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?
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 | — |
What is it indicated for?
Bonding between dentin/enamel and composite filling materials.
Bonding between dentin/enamel and compomer filling materials.
Bonding mediator for fissure sealing
Bonding mediator for bracket attachment
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020946 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020946: Adper Prompt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020946
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026