510(k) · Cleared
ClearedPulpdent Solo Flowable Composite with MCP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulpdent Corporation · EBF Material, Tooth Shade, Resin
Cleared on Apr 1, 2016 as substantially equivalent to K130223 (Pulpdent Corporation, 2013) after a 144-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it.
- Decided
- Apr 1, 2016
- Review
- 144 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K933139 (1994). 14 ancestors in all, the oldest K925032 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK933139 3M Vitremer Luting Cement3M Company · 1994
- 4 generations backK022476 Relyx Rmgip3M Company · 2002
- 3 generations backK111185 Relyx Luting Plus Automix3M Espe Dental Products · 2011
- 2 generations backK123265 Rmgi Low ViscosityPulpdent Corporation · 2012
- 1 generation backK130223 Rmgi FillPulpdent Corporation · 2013
- This deviceK153249 Pulpdent Solo Flowable Composite with MCPPulpdent Corporation · 2016
- Descendant · cites it directly · 0 of its ownK210045 Activa Presto PackPulpdent Corporation · 2021
Most influential descendants
Showing 1 of 1 · See all- K210045Activa Presto PackPulpdent Corporation · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933139 | 3M Vitremer Luting Cement | 3M Company | 1994 | — |
| −4 | K022476 | Relyx Rmgip | 3M Company | 2002 | — |
| −3 | K111185 | Relyx Luting Plus Automix | 3M Espe Dental Products | 2011 | — |
| −2 | K123265 | Rmgi Low Viscosity | Pulpdent Corporation | 2012 | — |
| −1 | K130223 | Rmgi Fill | Pulpdent Corporation | 2013 | — |
| 0 (this device) | K153249 | Pulpdent Solo Flowable Composite with MCP | Pulpdent Corporation | 2016 | — |
| +1 | K210045 | Activa Presto Pack | Pulpdent Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 EBF? 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 EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 generations · 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 |
|---|---|---|---|
| * | K130223 | Rmgi FillSummary page 4…Device Class: II Classification Name: Tooth-shade resin material FDA Product Code: EBF PREDICATE DEVICE: Pulpdent ACTIVA BioACTIVE-RESTORATIVE, K130223 (Pulpdent RMGI Fill) NOTE: Pulpdent RMGI Fill was the working name for ACTIVA BioACTIVE-RESTORATIVE that was used dur… | 2013 |
| † | K103585 | Bosworth Aegis Liner & Restorative Material W/Acp | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210045 | Activa Presto Pack | 2021 | 0 |
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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K210045 (Pulpdent Corporation, 2021) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K130223.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, 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 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
What is it indicated for?
Pulpdent Solo Flowable Composite with MCP is a fluoride, calcium and
phosphate-releasing flowable composite used by dental professionals as a
restorative, base and liner.
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/K153249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153249: Pulpdent Solo Flowable Composite with MCP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153249
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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