510(k) · Cleared
ClearedClip Flow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Voco GmbH · EBF Material, Tooth Shade, Resin
Cleared on Jul 29, 2016 after a 238-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Jul 29, 2016
- Review
- 238 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK153493 Clip FlowVoco GmbH · 2016
- Descendant · cites it directly · 0 of its ownK251283 Once-Fil FlowMediclus Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK250778 Sil-FlowDsi Dental Solutions, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK221909 J-TempUltradent Products, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK192022 DiaTemp FlowDiaDent Group International · 2020
Most influential descendants
Showing 4 of 4 · See all- K251283Once-Fil FlowMediclus Co., Ltd. · 2025 · cites it directly0descendants
- K250778Sil-FlowDsi Dental Solutions, Ltd. · 2025 · cites it directly0descendants
- K221909J-TempUltradent Products, Inc. · 2022 · cites it directly0descendants
- K192022DiaTemp FlowDiaDent Group International · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K153493 | Clip Flow | Voco GmbH | 2016 | — |
| +1 | K251283 | Once-Fil Flow | Mediclus Co., Ltd. | 2025 | — |
| +1 | K250778 | Sil-Flow | Dsi Dental Solutions, Ltd. | 2025 | — |
| +1 | K221909 | J-Temp | Ultradent Products, Inc. | 2022 | — |
| +1 | K192022 | DiaTemp Flow | DiaDent Group International | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
4 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, K251283 (Mediclus Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
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?
Clip Flow is intended for use as:
[A] Temporary inlay and onlay treatments of the cavity
[B] Sealing of openings for implant screws
[C] Relining material for temporary crowns and bridges
[D] Block-out material for retentive areas in the dental arch, e.g. before taking impressions
[E] Covering of the gingival margin
[F] Fixing of resin matrix during filling placement
[G] Temporary filling of cavities
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153493: Clip Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153493
Report an extraction error
Are you the manufacturer?
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