510(k) · Cleared
ClearedXP Bond Dual Cure Universal Total Etch Adhesive
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 Mar 14, 2007 as substantially equivalent to K050386 (Dentsply International, 2005) after a 16-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Mar 14, 2007
- Review
- 16 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K050386 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK050386 Prime & Bond NT Dual Cure Nano-Technology Universal Dental Adhesive…Dentsply International · 2005
- This deviceK070538 XP Bond Dual Cure Universal Total Etch AdhesiveDentsply Intl. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K050386 | Prime & Bond NT Dual Cure Nano-Technology Universal Dental Adhesive System | Dentsply International | 2005 | — |
| 0 (this device) | K070538 | XP Bond Dual Cure Universal Total Etch Adhesive | Dentsply Intl. | 2007 | — |
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? (1)
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 |
|---|---|---|---|
| * | K050386 | Prime & Bond NT Dual Cure Nano-Technology Universal Dental Adhesive SystemSummary page 1…CT CODE: KLE PREDICATE DEVICES: PRIME & BOND NT DUAL CURE NANO- TECHNOLOGY UNIVERSAL ADHESIVE, K050386 DEVICE DESCRIPTION: The XP BOND Dual Cure is a universal self-priming dental adhesive system designed to bond resin based mater… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K050386.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
XP BOND is indicated for
1. Direct, Light-cured composite and compomer restorative.
2. Indirect Restorations; Light-cured, resin cemented Veneers.
3. Composite, ceramic and amalgam repairs.
4. Cavity varnish for use with fresh amalgam.
5. Direct, dual cure or self-cure composite restorations and core build-ups.
6. Indirect restorations; Dual cured and self-cured resin cemented inlays, onlays, crown and bridge retainers.
7. Dual cured and self cured resin cemented Endodontic post cementation.
8. Adhesive bonding of direct amalgam restoration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070538: XP Bond Dual Cure Universal Total Etch Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070538
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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