510(k) · Cleared
ClearedXeno Iii Dental 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 Jan 23, 2003 as substantially equivalent to K982394 (Dentsply Intl., 1998) after a 72-day review. Its family tree reaches back 5 generations to 1993. 3 later devices descend from it.
- Decided
- Jan 23, 2003
- Review
- 72 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K931812 (1993). 8 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 4 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 3 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 2 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 1 generation backK982394 Prime & Bond NT Dual Cure Universal Dental Adhesive SystemDentsply Intl. · 1998
- This deviceK023776 Xeno Iii Dental AdhesiveDentsply Intl. · 2003
- Descendant · cites it directly · 1 of its ownK041960 Composite/Compomer Repair KitDmg USA, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK063444 Total Etch Bonding AgentDmg USA, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK061427 Pre-Impression Conditioning SolutionDentsply Intl. · 2006
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −4 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −3 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −2 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −1 | K982394 | Prime & Bond NT Dual Cure Universal Dental Adhesive System | Dentsply Intl. | 1998 | — |
| 0 (this device) | K023776 | Xeno Iii Dental Adhesive | Dentsply Intl. | 2003 | — |
| +1 | K041960 | Composite/Compomer Repair Kit | Dmg USA, Inc. | 2004 | — |
| +2 | K063444 | Total Etch Bonding Agent | Dmg USA, Inc. | 2007 | — |
| +1 | K061427 | Pre-Impression Conditioning Solution | Dentsply Intl. | 2006 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | K982394 | Prime & Bond NT Dual Cure Universal Dental Adhesive SystemSummary page 1…11 DENTAL ADHESIVE CLP SSIFICATION NAME: Resin tooth bonding agent (872.3200) PRE DICATE DEVICES: Prime & BondTMNTTMNano-Technology K982394 Light Cured Dental Adhesive DE' /ICE DESCRIPTION: XENOB 111 DENTAL ADHESIVE is a single step se… | 1998 |
What descends from it? (3)
2 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 10 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K041960 (Dmg USA, Inc., 2004) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K982394.
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?
Dental adhesive for direct light-cured composite restorative materials
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023776 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023776: Xeno Iii Dental Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023776
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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