510(k) · Cleared
Recalled · Class II · 2017Multiple Resin Tooth Bonding Agent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cosmedent, Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Oct 21, 2005 as substantially equivalent to K910860 (Bisco, Inc., 1991) after a 38-day review. Its family tree reaches back 1 generation to 1991. 3 later devices descend from it. It has been recalled once.
- Decided
- Oct 21, 2005
- Review
- 38 days
- Class
- Class II
- Product code
- KLE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910860 (1991). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK910860 All-Bond 2Bisco, Inc. · 1991
- This deviceK052501 Multiple Resin Tooth Bonding AgentCosmedent, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK143694 Rhondium One-Visit-Crown (OVC)Rhondium, Ltd. · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK172952 Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown KitFigaro Crowns, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK162677 L- OVCRhondium, Ltd. · 2016
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 |
|---|---|---|---|---|---|
| −1 | K910860 | All-Bond 2 | Bisco, Inc. | 1991 | — |
| 0 (this device) | K052501 | Multiple Resin Tooth Bonding Agent | Cosmedent, Inc. | 2005 | — |
| +1 | K143694 | Rhondium One-Visit-Crown (OVC) | Rhondium, Ltd. | 2015 | 1 |
| +2 | K172952 | Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit | Figaro Crowns, Inc. | 2018 | — |
| +2 | K162677 | L- OVC | Rhondium, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K910860 | All-Bond 2Summary page 1…e or mixed with B and allowed to self cure. The safety and efficacy are otherwise equivalent. IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE Risco All-Bond 2 (K910860) is a dual-cure 4th generation resin tooth bonding agent based on an acetone solution of room temperature polymerizing dimethacry… | 1991 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143694 | Rhondium One-Visit-Crown (OVC) | 2015 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 28, 2017 | Class II | Z-0741-2018 | Under Investigation by firm | Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
Resin Tooth Bonding Agent is used to facilitate the adhesive bonding of
restorative/preventive dental materials to dental hard tissues as well as to other
restorative materials.
Resin Tooth Bonding Agent is marketed as a kit that may contain:
* A single light-cure resin component
* A two-component self-cure resin adhesive
* A phosphoric acid etchant
* A silane coupling agent
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052501 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052501: Multiple Resin Tooth Bonding Agent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052501
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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