510(k) · Cleared
ClearedTENURE4G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Den-Mat Holdings, LLC · KLE Agent, Tooth Bonding, Resin
Cleared on Aug 20, 2014 as substantially equivalent to K910860 (Bisco, Inc., 1991) and 1 other predicate after a 169-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Aug 20, 2014
- Review
- 169 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K872510 (1987). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK872510 Den-Mat TenureDen-Mat Corp. · 1987
- This deviceK140537 TENURE4GDen-Mat Holdings, LLC · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872510 | Den-Mat Tenure | Den-Mat Corp. | 1987 | — |
| 0 (this device) | K140537 | TENURE4G | Den-Mat Holdings, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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 |
|---|---|---|---|
| * | K910860 | All-Bond 2Summary page 4…05 346 3700 805 347 7940 Helen Ragus Regulatory Specialist 805 346 3700. X2932 hravusidenmat.com FFebruary 24, 2014 tenure* 4G Bonding Agent Agent, Tooth Bonding K910860 K872510 Description of the Device tenure*4G is DenMat’s next generation of its ?opular Tenure MPB System with g… | 1991 |
| * | K872510 | Den-Mat TenureSummary page 4…00 805 347 7940 Helen Ragus Regulatory Specialist 805 346 3700. X2932 hravusidenmat.com FFebruary 24, 2014 tenure* 4G Bonding Agent Agent, Tooth Bonding K910860 K872510 Description of the Device tenure*4G is DenMat’s next generation of its ?opular Tenure MPB System with greater bo… | 1987 |
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?
- None of the 2 ancestors has a recall.
- 6 other devices also cite its predicate K910860.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
tenure®4G is recommended for the following types of applications:
1) All routine direct and indirect resin composite bonding
2) Porcelain, ceramic veneers, amalgams, precious and semi-precious metals bonding
3) Indirect gold, porcelain and ceramic inlays and onlays bonding
4) Desensitization of root or dentin prior to impressions or temporaries
5) Preparation desensitization of crown prior to impressions or temporaries
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/K140537 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140537: TENURE4G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140537
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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