510(k) · Cleared
ClearedOrajel Advanced Tooth Desensitizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Del Pharmaceuticals, Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Nov 10, 2004 after a 142-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 12 later devices descend from it.
- Decided
- Nov 10, 2004
- Review
- 142 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 3 citing it directly.
- This deviceK041680 Orajel Advanced Tooth DesensitizerDel Pharmaceuticals, Inc. · 2004
- Descendant · cites it directly · 10 of its ownK050486 Protect Tooth DesensitizerSunstar Butler · 2005
- Descendant · cites it directly · 6 of its ownK120109 Super Seal Tooth DesensitizerPhoenix Dental, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK082594 RemesenseRemedent NV · 2009
- Descendant · 2 generations on · 2 of its ownK120176 Senzzzzz AwayCentrix, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK103461 Colgate Desensitizing Dental CreamColgate-Palmolive Co. · 2011
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K050486Protect Tooth DesensitizerSunstar Butler · 2005 · cites it directly10descendants
- K120109Super Seal Tooth DesensitizerPhoenix Dental, Inc. · 2012 · cites it directly6descendants
- K082594RemesenseRemedent NV · 2009 · cites it directly3descendants
- K120176Senzzzzz AwayCentrix, Inc. · 2012 · 2 generations on2descendants
- K103461Colgate Desensitizing Dental CreamColgate-Palmolive Co. · 2011 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041680 | Orajel Advanced Tooth Desensitizer | Del Pharmaceuticals, Inc. | 2004 | — |
| +1 | K050486 | Protect Tooth Desensitizer | Sunstar Butler | 2005 | — |
| +1 | K120109 | Super Seal Tooth Desensitizer | Phoenix Dental, Inc. | 2012 | — |
| +1 | K082594 | Remesense | Remedent NV | 2009 | — |
| +2 | K120176 | Senzzzzz Away | Centrix, Inc. | 2012 | — |
| +2 | K103461 | Colgate Desensitizing Dental Cream | Colgate-Palmolive Co. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (12)
See all 123 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?
- Of its descendants, K050486 (Sunstar Butler, 2005) has gone furthest, with 10 descendants of its own.
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?
Tooth Desensitizer
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K041680 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041680: Orajel Advanced Tooth Desensitizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041680
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)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026