510(k) · Cleared
ClearedDelton F Pit & Fissure Sealant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · EBC Sealant, Pit And Fissure, And Conditioner
Cleared on May 3, 1995 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- May 3, 1995
- Review
- 42 days
- Class
- Class II
- Product code
- EBC
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK951296 Delton F Pit & Fissure SealantDentsply Intl. · 1995
- Descendant · cites it directly · 2 of its ownK982564 Delton FS Direct Delivery SystemDentsply Intl. · 1998
- Descendant · cites it directly · 1 of its ownK050959 Delton Illuminating Pit and Fissure SealingDentsply International · 2005
- Descendant · 2 generations on · 0 of its ownK101245 Ultraseal IDUltradent Products, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK992516 Dyract Seal Compomer Pit & Fissure SealantDentsply Intl. · 1999
- Descendant · cites it directly · 0 of its ownK991909 Delton FS with Fluoride Pit & Fissure SealantDentsply Intl. · 1999
Most influential descendants
Showing 5 of 5 · See all- K982564Delton FS Direct Delivery SystemDentsply Intl. · 1998 · cites it directly2descendants
- K050959Delton Illuminating Pit and Fissure SealingDentsply International · 2005 · cites it directly1descendant
- K101245Ultraseal IDUltradent Products, Inc. · 2010 · 2 generations on0descendants
- K992516Dyract Seal Compomer Pit & Fissure SealantDentsply Intl. · 1999 · 2 generations on0descendants
- K991909Delton FS with Fluoride Pit & Fissure SealantDentsply Intl. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951296 | Delton F Pit & Fissure Sealant | Dentsply Intl. | 1995 | — |
| +1 | K982564 | Delton FS Direct Delivery System | Dentsply Intl. | 1998 | — |
| +1 | K050959 | Delton Illuminating Pit and Fissure Sealing | Dentsply International | 2005 | — |
| +2 | K101245 | Ultraseal ID | Ultradent Products, Inc. | 2010 | — |
| +2 | K992516 | Dyract Seal Compomer Pit & Fissure Sealant | Dentsply Intl. | 1999 | — |
| +1 | K991909 | Delton FS with Fluoride Pit & Fissure Sealant | Dentsply Intl. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
3 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, K982564 (Dentsply Intl., 1998) 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 | — |
https://510kreport.com/device/K951296 · printed Nov 5, 2026
Cite this page
510(k) Report. “K951296: Delton F Pit & Fissure Sealant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951296
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026