510(k) · Cleared
ClearedEsCom250
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spident Co., Ltd. · EBF Material, Tooth Shade, Resin
Cleared on Jul 24, 2023 as substantially equivalent to K183476 (3M Espe Dental Products, 2019) after a 59-day review. Its family tree reaches back 3 generations to 2008.
- Decided
- Jul 24, 2023
- Review
- 59 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K083610 (2008). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK083610 Filtek Supreme Ultra Universal Restorative3M Company · 2008
- 2 generations backK141081 Filtek Bulk Fill Posterior Restroative3M Espe Dental Products · 2014
- 1 generation backK183476 3M Filtek Universal Restorative3M Espe Dental Products · 2019
- This deviceK231523 EsCom250Spident Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K083610 | Filtek Supreme Ultra Universal Restorative | 3M Company | 2008 | — |
| −2 | K141081 | Filtek Bulk Fill Posterior Restroative | 3M Espe Dental Products | 2014 | — |
| −1 | K183476 | 3M Filtek Universal Restorative | 3M Espe Dental Products | 2019 | — |
| 0 (this device) | K231523 | EsCom250 | Spident Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K183476 | 3M Filtek Universal RestorativeSummary page 4…lass : II 3. Predicate Devices (Legally Marketed Devices) The predicate devices for EsCom250 is : ⚫ Filtek Z250 Universal Restorative, 3M ESPE Dental Products, K183476 4. Description: EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K183476.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Direct anterior and posterior restorations
Restoration of fractured (broken) teeth due to trauma
Restoration of deciduous teeth
Direct restorative for diastema closure
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/K231523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231523: EsCom250.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231523
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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