510(k) · Cleared
ClearedDentition Integrating Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulpdent Corporation · EBC Sealant, Pit And Fissure, And Conditioner
Cleared on Apr 12, 2002 after a 74-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Apr 12, 2002
- Review
- 74 days
- Class
- Class II
- Product code
- EBC
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK020287 Dentition Integrating MaterialPulpdent Corporation · 2002
- Descendant · cites it directly · 1 of its ownK172169 Pulpdent (Activa) Pit and Fissure Sealant with MCPPulpdent Corporation · 2018
- Descendant · 2 generations on · 0 of its ownK190998 BA Pit & Fissure SealantApex Dental Materials, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK113818 Embrace Wetbond Pit and Fissure Sealant, Low FillPulpdent Corporation · 2012
- Descendant · cites it directly · 0 of its ownK113617 Spee-Dee PatchPulpdent Corporation · 2012
Most influential descendants
Showing 4 of 4 · See all- K172169Pulpdent (Activa) Pit and Fissure Sealant with MCPPulpdent Corporation · 2018 · cites it directly1descendant
- K190998BA Pit & Fissure SealantApex Dental Materials, Inc. · 2019 · 2 generations on0descendants
- K113818Embrace Wetbond Pit and Fissure Sealant, Low FillPulpdent Corporation · 2012 · cites it directly0descendants
- K113617Spee-Dee PatchPulpdent Corporation · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020287 | Dentition Integrating Material | Pulpdent Corporation | 2002 | — |
| +1 | K172169 | Pulpdent (Activa) Pit and Fissure Sealant with MCP | Pulpdent Corporation | 2018 | — |
| +2 | K190998 | BA Pit & Fissure Sealant | Apex Dental Materials, Inc. | 2019 | — |
| +1 | K113818 | Embrace Wetbond Pit and Fissure Sealant, Low Fill | Pulpdent Corporation | 2012 | — |
| +1 | K113617 | Spee-Dee Patch | Pulpdent Corporation | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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? (6)
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 |
|---|---|---|---|
| * | — | Pulpdent Flows-Rite Named without a submission number | |
| * | — | Pulpdent Seal-Rite Pit and Fissure Sealant Named without a submission number | |
| * | — | Pulpdent Seal-Rite Low Viscosity Pit and Fissure Sealant Named without a submission number | |
| * | — | Pulpdent Seal-Rite UDMA Named without a submission number | |
| * | — | Kuraray Clear-Fil Named without a submission number | |
| * | — | Kerr OptiBond Solo Plus 3 Named without a submission number |
What descends from it? (4)
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, K172169 (Pulpdent Corporation, 2018) has gone furthest, with 1 descendant 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?
Pulpdent Dentition Integrating Material is a fluoride-releasing. light-cured, resin-based material that bonds tightly to dentition and is used to fill and seal the pits and fissures in teeth.
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/K020287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020287: Dentition Integrating Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020287
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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