510(k) · Cleared
ClearedDelton FS Direct Delivery System
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 Oct 6, 1998 as substantially equivalent to K951296 (Dentsply Intl., 1995) after a 75-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Oct 6, 1998
- Review
- 75 days
- Class
- Class II
- Product code
- EBC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951296 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK951296 Delton F Pit & Fissure SealantDentsply Intl. · 1995
- This deviceK982564 Delton FS Direct Delivery SystemDentsply Intl. · 1998
- Descendant · cites it directly · 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951296 | Delton F Pit & Fissure Sealant | Dentsply Intl. | 1995 | — |
| 0 (this device) | K982564 | Delton FS Direct Delivery System | Dentsply Intl. | 1998 | — |
| +1 | 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 |
|---|---|---|
| 1999 | 2 | 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 |
|---|---|---|---|
| * | K951296 | Delton F Pit & Fissure Sealant Our OCR of the scanned summary read K851296, FDA’s number for Implantable Electrode Lead 030-269 Using Polyureth (Telectronics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “DELTON® Plus Direct Delivery System”. | 1995 |
| † | K942031 | Caulk Tooth Conditioner Gel and Syringe | 1994 |
What descends from it? (2)
2 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?
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?
The DELTON® FS DIRECT DELIVERY SYSTEM is used for preventive
sealing of pits and fissures in the primary and secondary dentition
in combination with the acid-etch technique.
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/K982564 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982564: Delton FS Direct Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982564
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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