510(k) · Cleared
ClearedPrime & Bond NT Dual Cure Universal Dental Adhesive System
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 Sep 21, 1998 as substantially equivalent to K962348 (Dentsply Intl., 1996) and 1 other predicate after a 74-day review. Its family tree reaches back 4 generations to 1993. 22 later devices descend from it.
- Decided
- Sep 21, 1998
- Review
- 74 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K931812 (1993). 7 ancestors in all. 22 later devices descend from it, 8 citing it directly.
- Root · 4 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 3 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 2 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 1 generation backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- This deviceK982394 Prime & Bond NT Dual Cure Universal Dental Adhesive SystemDentsply Intl. · 1998
- Descendant · cites it directly · 9 of its ownK992822 Seal & Protect Protective Sealant for Exposed DentineDentsply Intl. · 1999
- Descendant · 2 generations on · 4 of its ownK021805 Seal & Protect Protective SealantDentsply Intl. · 2002
- Descendant · cites it directly · 3 of its ownK023842 Clearfil SE Bond PlusKuraray Medical, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK023776 Xeno Iii Dental AdhesiveDentsply Intl. · 2003
- Descendant · 2 generations on · 3 of its ownK003482 Proclude-SensitiveOrtek Therapeutics, Inc. · 2001
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K992822Seal & Protect Protective Sealant for Exposed DentineDentsply Intl. · 1999 · cites it directly9descendants
- K021805Seal & Protect Protective SealantDentsply Intl. · 2002 · 2 generations on4descendants
- K023842Clearfil SE Bond PlusKuraray Medical, Inc. · 2003 · cites it directly3descendants
- K023776Xeno Iii Dental AdhesiveDentsply Intl. · 2003 · cites it directly3descendants
- K003482Proclude-SensitiveOrtek Therapeutics, Inc. · 2001 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −3 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −2 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −1 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| 0 (this device) | K982394 | Prime & Bond NT Dual Cure Universal Dental Adhesive System | Dentsply Intl. | 1998 | — |
| +1 | K992822 | Seal & Protect Protective Sealant for Exposed Dentine | Dentsply Intl. | 1999 | — |
| +2 | K021805 | Seal & Protect Protective Sealant | Dentsply Intl. | 2002 | — |
| +1 | K023842 | Clearfil SE Bond Plus | Kuraray Medical, Inc. | 2003 | — |
| +1 | K023776 | Xeno Iii Dental Adhesive | Dentsply Intl. | 2003 | — |
| +2 | K003482 | Proclude-Sensitive | Ortek Therapeutics, Inc. | 2001 | — |
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 |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2019 | 1 | 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 |
|---|---|---|---|
| * | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentSummary page 1…UNIVERSAL DENTAL ADHESIVE SYSTEM CLASSIFICATION NAME: Resin tooth bonding agent 872.3200 PREDICATE DEVICES: Prime & Bond® 2.1 Dual Cure Universal Dental Adhesive System K962348, K964525 DEVICE DESCRIPTION: PRIME & BOND® NT™ BONDING AGENT is a one-component, no-mix visible light-curable dental bonding age… | 1996 |
| * | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorSummary page 1…DENTAL ADHESIVE SYSTEM CLASSIFICATION NAME: Resin tooth bonding agent 872.3200 PREDICATE DEVICES: Prime & Bond® 2.1 Dual Cure Universal Dental Adhesive System K962348, K964525 DEVICE DESCRIPTION: PRIME & BOND® NT™ BONDING AGENT is a one-component, no-mix visible light-curable dental bonding agent that c… | 1997 |
What descends from it? (22)
See all 228 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992822 | Seal & Protect Protective Sealant for Exposed Dentine | 1999 | 9 |
| K023842 | Clearfil SE Bond Plus | 2003 | 3 |
| K023776 | Xeno Iii Dental Adhesive | 2003 | 3 |
| K041343 | Xeno NM Light Cured Dental Adhesive | 2004 | 2 |
| K070413 | Ascent Universal Adhesive, Model 006-00028 | 2007 | 1 |
| K012082 | Optibond Solo Plus Activator | 2001 | 1 |
| K122522 | Dentoetch Quickbond Bond Activator | 2013 | 0 |
| K992518 | Prime & Bond NT Dual Cure Universal Dental Adhesive System | 1999 | 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?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K992822 (Dentsply Intl., 1999) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K962348.
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?
Direct composite and compomer restorations
Composite, ceramic and amalgam repairs
Cavity varnish for use with fresh amalgam
Indirect restorations: Dual Cure, inlays, onlays, veneers, crowns and bridges
Endodontic post cementation
Adhesive bonding of direct amalgam restorations
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/K982394 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982394: Prime & Bond NT Dual Cure Universal Dental Adhesive System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982394
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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