510(k) · Cleared
ClearedDentin Desensitizer Agent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl., Inc. · LBH Varnish, Cavity
Cleared on Dec 19, 2007 as substantially equivalent to K962812 (Heraeus Kulzer, Inc., 1996) and 1 other predicate after a 44-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Dec 19, 2007
- Review
- 44 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K962812 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK962812 Gluma Desensitizer/Gluma 3 PrimerHeraeus Kulzer, Inc. · 1996
- This deviceK073117 Dentin Desensitizer AgentDentsply Intl., Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962812 | Gluma Desensitizer/Gluma 3 Primer | Heraeus Kulzer, Inc. | 1996 | — |
| 0 (this device) | K073117 | Dentin Desensitizer Agent | Dentsply Intl., Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 LBH? 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 LBH device
- #1 K262243 Profisil Freescore 12.9 · 4 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 |
|---|---|---|---|
| * | K962812 | Gluma Desensitizer/Gluma 3 PrimerSummary page 1…DENTIN DESENSITIZER AGENT CLASSIFICATION NAME: Resin Tooth Bonding Agent 872.3200 PREDICATE DEVICES: Gluma Desensitizer K9628 12 Quell Desensitizer K010957 DEVICE DESCRIPTION: The DENTIN DESENSITIZER AGENT is a chai… | 1996 |
| * | K010957 | Quell DesensitizerSummary page 1…Resin Tooth Bonding Agent 872.3200 PREDICATE DEVICES: Gluma Desensitizer K9628 12 Quell Desensitizer K010957 DEVICE DESCRIPTION: The DENTIN DESENSITIZER AGENT is a chair-side agent for treating and preventing dentinal hypersensitivity.… | 2001 |
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.
- 2 other devices also cite its predicate K962812.
How does its category compare?
All LBH devicesLBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LBH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LBH
223in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LBH
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBH
7in 2025
MAUDE reports naming product code LBH, 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 | 8 | 69 | 0 | 4 |
| 2008 | 6 | 79 | 0 | 3 |
| 2009 | 4 | 69 | 0 | 5 |
| 2010 | 7 | 107 | 0 | 7 |
| 2011 | 3 | 72 | 0 | 8 |
| 2012 | 4 | 83 | 0 | 7 |
| 2013 | 6 | 160 | 0 | 27 |
| 2014 | 6 | 204 | 3 | 40 |
| 2015 | 2 | — | 0 | 14 |
| 2016 | 2 | — | 0 | 12 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 2 | 13 |
| 2019 | 2 | — | 1 | 9 |
| 2020 | 5 | 256 | 0 | 10 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 1 | — | 0 | 7 |
| 2023 | 3 | 167 | 0 | 8 |
| 2024 | 3 | 237 | 0 | 6 |
| 2025 | 4 | 223 | 0 | 7 |
| 2026 | 5 | 64 | 0 | — |
What is it indicated for?
Treating and preventing dentinal hypersensitivity. Can be used under direct restorations, under indirect restorations, and on cervical sensitivity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073117 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073117: Dentin Desensitizer Agent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073117
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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