510(k) · Cleared
ClearedKerr Advanced Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kerr Dental Materials Center · KLE Agent, Tooth Bonding, Resin
Cleared on Aug 1, 1996 after a 35-day review. The FDA summary names its predicate without a number.
- Decided
- Aug 1, 1996
- Review
- 35 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (3)
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 |
|---|---|---|---|
| * | — | Prime & Bond Named without a submission number | |
| * | — | One-Step Named without a submission number | |
| * | — | Tenure QUIK Named without a submission number |
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.
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?
Kerr Advanced Adhesive is an all purpose dental adhesive consisting of a visible light curable methacrylate resin based mixture of monomers capable of forming both chemical and mechanical adhesive bonds to both natural tooth structures ( enamel and dentin ) and to commonly used restorative materials ( composite resins, porcelain and metals ). It is supplied as a one bottle, single step dental adhesive that is simple to use and produces fast, strong…
Read the full statement (123 words)
Kerr Advanced Adhesive is an all purpose dental adhesive consisting of a visible light curable methacrylate resin based mixture of monomers capable of forming both chemical and mechanical adhesive bonds to both natural tooth structures ( enamel and dentin ) and to commonly used restorative materials ( composite resins, porcelain and metals ). It is supplied as a one bottle, single step dental adhesive that is simple to use and produces fast, strong adhesion suitable for all commonly used restorative techniques. The organic solvent component allows the application of the adhesive to flow into micro-fissures of the substrate smoothly and when the fast evaporating solvent is removed a thin resin layer remains to form a tight bonding interface between tooth and restorative material.
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/K962515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962515: Kerr Advanced Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962515
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026