510(k) · Cleared
ClearedResin Tooth Bonding Agent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Parkell, Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Feb 7, 2000 after a 48-day review. The FDA summary names its predicate without a number.
- Decided
- Feb 7, 2000
- Review
- 48 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 |
|---|---|---|---|
| * | — | Gluma One Bond Named without a submission number | |
| * | — | Clearfil SE Bond Named without a submission number | |
| * | — | Optibond Solo 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?
This material is indicated for the following: 1. A dentin bonding agent used with direct filling materials that include but may not be limited to, composite resins, resin modified glass ionomers or compomers, etc. 2. A dentin bonding agent used with resin cements or composite luting agents to retain indirect tooth-colored restorations that include but may not be limited to indirect composite or porcelain inlays and onlays, lamin veneers, either resin or…
Read the full statement (111 words)
This material is indicated for the following:
1. A dentin bonding agent used with direct filling materials that include but may not be limited to, composite resins, resin modified glass ionomers or compomers, etc.
2. A dentin bonding agent used with resin cements or composite luting agents to retain indirect tooth-colored restorations that include but may not be limited to indirect composite or porcelain inlays and onlays, lamin veneers, either resin or porcelain, etc.
3. Treatment of hypersensitive areas of exposed root surfaces.
4. A cavity sealant applied to exposed dentin that has been prepared to receive a laboratory fabricated restoration such as porcelain-fused-to-metal crowns, cast alloy inlays or onlays, etc.
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/K994302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994302: Resin Tooth Bonding Agent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994302
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026