510(k) · Cleared
ClearedDIAFIL & DIAFIL Capsule
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaDent Group International · EBF Material, Tooth Shade, Resin
Cleared on Mar 20, 2020 as substantially equivalent to K042124 (Vericom Co., Ltd., 2004) after a 190-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it.
- Decided
- Mar 20, 2020
- Review
- 190 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K943168 (1994). 5 ancestors in all, the oldest K863092 (1986). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK943168 Clearfil AP-XKuraray Company, Ltd. · 1994
- 3 generations backK012740 Clearfil AP-XKuraray Medical, Inc. · 2001
- 2 generations backK023002 Clearfil AP-X PLTKuraray Medical, Inc. · 2002
- 1 generation backK042124 DenfilVericom Co., Ltd. · 2004
- This deviceK192510 DIAFIL & DIAFIL CapsuleDiaDent Group International · 2020
- Descendant · cites it directly · 0 of its ownK261093 DiafilDiaDent Group International · 2026
- Descendant · cites it directly · 0 of its ownK210421 Diafil & Diafil CapsuleDiaDent Group International · 2021
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 |
|---|---|---|---|---|---|
| −4 | K943168 | Clearfil AP-X | Kuraray Company, Ltd. | 1994 | — |
| −3 | K012740 | Clearfil AP-X | Kuraray Medical, Inc. | 2001 | — |
| −2 | K023002 | Clearfil AP-X PLT | Kuraray Medical, Inc. | 2002 | — |
| −1 | K042124 | Denfil | Vericom Co., Ltd. | 2004 | — |
| 0 (this device) | K192510 | DIAFIL & DIAFIL Capsule | DiaDent Group International | 2020 | — |
| +1 | K261093 | Diafil | DiaDent Group International | 2026 | — |
| +1 | K210421 | Diafil & Diafil Capsule | DiaDent Group International | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K042124 | DenfilSummary page 4…The legally marketed devices to which substantial equivalence is being claimed are: Primary Predicate Device 510(k) Number: K042124 Applicant: Vericom Device Name: DenFil Regulation Number: 21 CFR 872.3690 Product Co… | 2004 |
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?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K261093 (DiaDent Group International, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K042124.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
A composite material which has resin organic and inorganic fillers or complex fillers as ingredients, which are being used for aesthetic restoration by getting polymerized directly in the oral cavity.
- Direct anterior and posterior restorations
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/K192510 · printed Nov 3, 2026
Cite this page
510(k) Report. “K192510: DIAFIL & DIAFIL Capsule.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192510
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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