510(k) · Cleared
Cleared3M Dent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · KLE Agent, Tooth Bonding, Resin
Cleared on Aug 12, 1996 as substantially equivalent to K942493 (3M Company, 1994) and 1 other predicate after a 26-day review. Its family tree reaches back 1 generation to 1994. 45 later devices descend from it.
- Decided
- Aug 12, 1996
- Review
- 26 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K942493 (1994). 2 ancestors in all. 45 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK942493 Scotchbond Multi-Purpose Plus Dental Adhesive System3M Company · 1994
- This deviceK962785 3M Dent System3M Company · 1996
- 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 · cites it directly · 34 of its ownK110302 Adhesive Exl-7593M Espe AG · 2011
- Descendant · 2 generations on · 8 of its ownK112118 DreambondBisco, Inc. · 2011
- Descendant · 3 generations on · 6 of its ownK161051 All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · 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 · cites it directly34descendants
- K112118DreambondBisco, Inc. · 2011 · 2 generations on8descendants
- K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942493 | Scotchbond Multi-Purpose Plus Dental Adhesive System | 3M Company | 1994 | — |
| 0 (this device) | K962785 | 3M Dent System | 3M Company | 1996 | — |
| +1 | K060684 | Adper Prompt, Adper Prompt L-Pop | 3M Espe AG Dental Products | 2006 | — |
| +2 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| +1 | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
| +2 | K112118 | Dreambond | Bisco, Inc. | 2011 | — |
| +3 | K161051 | All-Bond Universal w/BAC (not finalized) | Bisco, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2011 | 3 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 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? (3)
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 |
|---|---|---|---|
| * | K942493 | Scotchbond Multi-Purpose Plus Dental Adhesive SystemSummary page 1…based dental adhesive system Classification Name: resin tooth bonding agent (21CFR872.3200) Predicate devices: 3M™ Scotchbond™ Multi-Purpose Plus Dental Adhesive System (K942493) Prime & Bond™ Direct Composite Bonding Agent (K951864) One Step™ Universal Dental Adhesive System (K# unknown) The 3M™ Dent Sys… | 1994 |
| * | K951864 | Prime & Bond Direct Composite Bonding AgentSummary page 1…tooth bonding agent (21CFR872.3200) Predicate devices: 3M™ Scotchbond™ Multi-Purpose Plus Dental Adhesive System (K942493) Prime & Bond™ Direct Composite Bonding Agent (K951864) One Step™ Universal Dental Adhesive System (K# unknown) The 3M™ Dent System is a simple adhesive system that offers the dental… | 1995 |
| * | — | One Step™ Universal Dental Adhesive System Named without a submission number |
What descends from it? (45)
See all 458 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060684 | Adper Prompt, Adper Prompt L-Pop | 2006 | 38 |
| K110302 | Adhesive Exl-759 | 2011 | 34 |
| K110403 | Prolink Adhesives (Prolink, Prolink SE) | 2011 | 1 |
| K183424 | Ambar, Ambar APS, Ambar Universal APS | 2019 | 0 |
| K181910 | BracePaste MTP Light Cure Primer | 2018 | 0 |
| K172977 | Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel | 2018 | 0 |
| K132923 | Fusion Single Link | 2014 | 0 |
| K070956 | SEA2 Self Etch Adhesive | 2007 | 0 |
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 | — |
https://510kreport.com/device/K962785 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962785: 3M Dent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962785
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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