510(k) · Cleared
ClearedPrime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · KLE Agent, Tooth Bonding, Resin
Cleared on Jan 22, 1997 as substantially equivalent to K942493 (3M Company, 1994) and 1 other predicate after a 71-day review. Its family tree reaches back 3 generations to 1993. 86 later devices descend from it.
- Decided
- Jan 22, 1997
- Review
- 71 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K931812 (1993). 6 ancestors in all. 86 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 2 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 1 generation backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- This deviceK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- Descendant · cites it directly · 67 of its ownK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
- Descendant · cites it directly · 64 of its ownK990040 Clearfil SE BondKuraray Co. · 1999
- Descendant · 2 generations on · 60 of its ownK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
- Descendant · 3 generations on · 34 of its ownK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
- Descendant · 4 generations on · 22 of its ownK094007 Unicem3M Espe AG Dental Products · 2010
Showing 5 of 86 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 86 · See all- K974486Clearfil Liner Bond 2VKuraray America, Inc. · 1998 · cites it directly67descendants
- K990040Clearfil SE BondKuraray Co. · 1999 · cites it directly64descendants
- K012442Modification to Clearfil SE BondKuraray Medical, Inc. · 2001 · 2 generations on60descendants
- K032455Panavia F 2.0Kuraray Medical, Inc. · 2003 · 3 generations on34descendants
- K094007Unicem3M Espe AG Dental Products · 2010 · 4 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −2 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −1 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| 0 (this device) | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| +1 | K974486 | Clearfil Liner Bond 2V | Kuraray America, Inc. | 1998 | — |
| +1 | K990040 | Clearfil SE Bond | Kuraray Co. | 1999 | — |
| +2 | K012442 | Modification to Clearfil SE Bond | Kuraray Medical, Inc. | 2001 | — |
| +3 | K032455 | Panavia F 2.0 | Kuraray Medical, Inc. | 2003 | — |
| +4 | K094007 | Unicem | 3M Espe AG Dental Products | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 6 | 0 |
| 2007 | 6 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 1 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 7 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K942493 | Scotchbond Multi-Purpose Plus Dental Adhesive SystemSummary page 1…ATOR COMMON OR USUAL NAME: Bonding agent CLASSIFICATION NAME: Resin tooth bonding agent 21 CFR, 872.3200 PREDICATE DEVICES: Scotchbond M.P. Plus Dental Adhesfve System K942493 Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent K962348 DESCRIPTION AND INTENDED USE: Prime & Bond™ 2.1 Multipurpose… | 1994 |
| * | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentSummary page 1…in tooth bonding agent 21 CFR, 872.3200 PREDICATE DEVICES: Scotchbond M.P. Plus Dental Adhesfve System K942493 Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent K962348 DESCRIPTION AND INTENDED USE: Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent is a one-component, no-mix visible ligh… | 1996 |
What descends from it? (86)
See all 864 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 1 company; a new generation was cleared every 6 months on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K974486 (Kuraray America, Inc., 1998) has gone furthest, with 67 descendants of its own.
- 3 other devices also cite its predicate K942493.
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?
use of the Bonding Agent and Activator together allows adhesion of amalgam restorations to tooth structures
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/K964525 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964525: Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964525
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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