510(k) · Cleared
ClearedPrime & Bond NT Dual Cure Nano-Technology Universal Dental Adhesive System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply International · KLE Agent, Tooth Bonding, Resin
Cleared on Feb 23, 2005 after an 8-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Feb 23, 2005
- Review
- 8 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK050386 Prime & Bond NT Dual Cure Nano-Technology Universal Dental Adhesive…Dentsply International · 2005
- Descendant · cites it directly · 1 of its ownK051463 Xeno Adhesive with ActivatorDentsply Intl. · 2005
- Descendant · 2 generations on · 0 of its ownK151619 Prime&Bond Elect Universal Dental AdhesiveDentsply International, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK131430 Clearfil DC Activator; Clearfil DC Activator TrialKuraray Noritake Dental, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK070538 XP Bond Dual Cure Universal Total Etch AdhesiveDentsply Intl. · 2007
Most influential descendants
Showing 4 of 4 · See all- K051463Xeno Adhesive with ActivatorDentsply Intl. · 2005 · cites it directly1descendant
- K151619Prime&Bond Elect Universal Dental AdhesiveDentsply International, Inc. · 2015 · 2 generations on0descendants
- K131430Clearfil DC Activator; Clearfil DC Activator TrialKuraray Noritake Dental, Inc. · 2013 · cites it directly0descendants
- K070538XP Bond Dual Cure Universal Total Etch AdhesiveDentsply Intl. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050386 | Prime & Bond NT Dual Cure Nano-Technology Universal Dental Adhesive System | Dentsply International | 2005 | — |
| +1 | K051463 | Xeno Adhesive with Activator | Dentsply Intl. | 2005 | — |
| +2 | K151619 | Prime&Bond Elect Universal Dental Adhesive | Dentsply International, Inc. | 2015 | — |
| +1 | K131430 | Clearfil DC Activator; Clearfil DC Activator Trial | Kuraray Noritake Dental, Inc. | 2013 | — |
| +1 | K070538 | XP Bond Dual Cure Universal Total Etch Adhesive | Dentsply Intl. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
3 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?
- Of its descendants, K051463 (Dentsply Intl., 2005) has gone furthest, with 1 descendant of its own.
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/K050386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050386: Prime & Bond NT Dual Cure Nano-Technology Universal Dental Adhesive System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050386
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026