510(k) · Cleared
Cleared3M Clinpro Sealant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · EBC Sealant, Pit And Fissure, And Conditioner
Cleared on Oct 8, 1999 after an 87-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Oct 8, 1999
- Review
- 87 days
- Class
- Class II
- Product code
- EBC
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 7 citing it directly.
- This deviceK992326 3M Clinpro Sealant3M Company · 1999
- Descendant · cites it directly · 2 of its ownK091632 SPK Sealant3M Company · 2009
- Descendant · 2 generations on · 1 of its ownK100062 Infiltration KitDmg USA, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK251124 G-Bond UniversalGC America, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK230455 Enamel Coating ResinRizhao Huge Biomaterials Company, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK162598 HAPI SealBisco, Inc. · 2017
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K091632SPK Sealant3M Company · 2009 · cites it directly2descendants
- K100062Infiltration KitDmg USA, Inc. · 2010 · 2 generations on1descendant
- K251124G-Bond UniversalGC America, Inc. · 2025 · 3 generations on0descendants
- K230455Enamel Coating ResinRizhao Huge Biomaterials Company, Ltd. · 2023 · cites it directly0descendants
- K162598HAPI SealBisco, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992326 | 3M Clinpro Sealant | 3M Company | 1999 | — |
| +1 | K091632 | SPK Sealant | 3M Company | 2009 | — |
| +2 | K100062 | Infiltration Kit | Dmg USA, Inc. | 2010 | — |
| +3 | K251124 | G-Bond Universal | GC America, Inc. | 2025 | — |
| +1 | K230455 | Enamel Coating Resin | Rizhao Huge Biomaterials Company, Ltd. | 2023 | — |
| +1 | K162598 | HAPI Seal | Bisco, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 EBC? 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 EBC device
- #1 K243254 Parkell Pit and Fissure Sealantscore 12.8 · 1 generation · 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 |
|---|---|---|---|
| * | — | 3M™ Concise™ Light Cure White Sealant Named without a submission number |
What descends from it? (9)
7 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, K091632 (3M Company, 2009) has gone furthest, with 2 descendants of its own.
How does its category compare?
All EBC devicesEBC Sealant, Pit And Fissure, And Conditioner: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBC
80in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBC
2in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBC
6in 2025
MAUDE reports naming product code EBC, 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 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 5 | 115 | 0 | 0 |
| 2011 | 3 | 80 | 0 | 5 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 11 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 1 | 0 |
| 2016 | 1 | — | 2 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 6 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
This device is indicated for:
Pit and fissure sealant
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/K992326 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992326: 3M Clinpro Sealant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992326
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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