510(k) · Cleared
ClearedAdper Prompt, Adper Prompt L-Pop
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 24, 2006 as substantially equivalent to K040857 (3M Espe AG Dental Products, 2004) and 1 other predicate after a 40-day review. Its family tree reaches back 3 generations to 2000. 38 later devices descend from it.
- Decided
- Apr 24, 2006
- Review
- 40 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K001494 (2000). 7 ancestors in all, the oldest K942493 (1994). 38 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK001494 Modification to Prompt L-PopEspe Dental AG · 2000
- 2 generations backK020946 Adper Prompt3M Espe AG Dental Products · 2002
- 1 generation backK040857 Modification to Adper Prompt3M Espe AG Dental Products · 2004
- This deviceK060684 Adper Prompt, Adper Prompt L-Pop3M Espe AG Dental Products · 2006
- 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 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · 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 |
|---|---|---|---|---|---|
| −3 | K001494 | Modification to Prompt L-Pop | Espe Dental AG | 2000 | — |
| −2 | K020946 | Adper Prompt | 3M Espe AG Dental Products | 2002 | — |
| −1 | K040857 | Modification to Adper Prompt | 3M Espe AG Dental Products | 2004 | — |
| 0 (this device) | K060684 | Adper Prompt, Adper Prompt L-Pop | 3M Espe AG Dental Products | 2006 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K040857 | Modification to Adper PromptSummary page 1…Common Name: Dental Adhesive Predicate Devices: Adper MT PromptTM, Adper TM Prompt TM L-PopTM by 3M ESPE (K040857) Adper T' M Single Bond Plus by 3M ESPE (K962785) traditional 510(k) Adper Prompt… | 2004 |
| * | K962785 | 3M Dent SystemSummary page 1…Predicate Devices: Adper MT PromptTM, Adper TM Prompt TM L-PopTM by 3M ESPE (K040857) Adper T' M Single Bond Plus by 3M ESPE (K962785) traditional 510(k) Adper Prompt Page 4 of 140 === Page 2… | 1996 |
What descends from it? (38)
See all 383 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 6 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K071131 (3M Espe AG Dental Products, 2007) has gone furthest, with 35 descendants of its own.
- 1 other device also cites its predicate K040857.
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
Bonding between RelyX TM Fiber Post root posts and light-curing composite core build-up materials
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060684: Adper Prompt, Adper 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/K060684
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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