510(k) · Cleared
ClearedModification to Adper 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 May 10, 2004 as substantially equivalent to K020946 (3M Espe AG Dental Products, 2002) and 1 other predicate after a 38-day review. Its family tree reaches back 2 generations to 2000. 39 later devices descend from it.
- Decided
- May 10, 2004
- Review
- 38 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K001494 (2000). 3 ancestors in all, the oldest K992292 (1999). 39 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK001494 Modification to Prompt L-PopEspe Dental AG · 2000
- 1 generation backK020946 Adper Prompt3M Espe AG Dental Products · 2002
- This deviceK040857 Modification to Adper Prompt3M Espe AG Dental Products · 2004
- Descendant · cites it directly · 38 of its ownK060684 Adper Prompt, Adper Prompt L-Pop3M Espe AG Dental Products · 2006
- 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
- Descendant · 4 generations on · 8 of its ownK112118 DreambondBisco, Inc. · 2011
- Descendant · 5 generations on · 6 of its ownK161051 All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K060684Adper Prompt, Adper Prompt L-Pop3M Espe AG Dental Products · 2006 · cites it directly38descendants
- K071131UNO3M Espe AG Dental Products · 2007 · 2 generations on35descendants
- K110302Adhesive Exl-7593M Espe AG · 2011 · 3 generations on34descendants
- K112118DreambondBisco, Inc. · 2011 · 4 generations on8descendants
- K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001494 | Modification to Prompt L-Pop | Espe Dental AG | 2000 | — |
| −1 | K020946 | Adper Prompt | 3M Espe AG Dental Products | 2002 | — |
| 0 (this device) | K040857 | Modification to Adper Prompt | 3M Espe AG Dental Products | 2004 | — |
| +1 | K060684 | Adper Prompt, Adper Prompt L-Pop | 3M Espe AG Dental Products | 2006 | — |
| +2 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| +3 | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
| +4 | K112118 | Dreambond | Bisco, Inc. | 2011 | — |
| +5 | K161051 | All-Bond Universal w/BAC (not finalized) | Bisco, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K020946 | Adper PromptSummary page 1…Common Name: .................... Dental Adhesive Predicate Devices: Adper Prompt by 3M ESPE ........... K 020946 Glumna Comfort Bond -i Desensitizer .... K 992292 by Heraeus Kulzer 510(k)… | 2002 |
| * | K992292 | Gluma Comfort Bond + DesensitizerSummary page 1…Predicate Devices: Adper Prompt by 3M ESPE ........... K 020946 Glumna Comfort Bond -i Desensitizer .... K 992292 by Heraeus Kulzer 510(k) Adper Prompt… | 1999 |
What descends from it? (39)
See all 392 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?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K060684 (3M Espe AG Dental Products, 2006) has gone furthest, with 38 descendants of its own.
- 3 other devices also cite its predicate K020946.
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
Desensitization of hypersensitive areas of teeth
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040857 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040857: Modification to Adper Prompt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040857
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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