510(k) · Cleared
ClearedVenus Diamond Flow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heraeus Kulzer, LLC · EBF Material, Tooth Shade, Resin
Cleared on Sep 3, 2009 after a 91-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Sep 3, 2009
- Review
- 91 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK091635 Venus Diamond FlowHeraeus Kulzer, LLC · 2009
- Descendant · cites it directly · 2 of its ownK220605 Venus Bulk Flow ONEKulzer, LLC · 2022
- Descendant · cites it directly · 0 of its ownK260783 Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow OneKulzer, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK250267 Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x…Kettenbach GmbH & Co. KG · 2025
- Descendant · cites it directly · 0 of its ownK141994 Bulk Fill Flowable CompositeNovocol, Inc. · 2014
Most influential descendants
Showing 4 of 4 · See all- K220605Venus Bulk Flow ONEKulzer, LLC · 2022 · cites it directly2descendants
- K260783Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow OneKulzer, LLC · 2026 · cites it directly0descendants
- K250267Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062)…Kettenbach GmbH & Co. KG · 2025 · 2 generations on0descendants
- K141994Bulk Fill Flowable CompositeNovocol, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091635 | Venus Diamond Flow | Heraeus Kulzer, LLC | 2009 | — |
| +1 | K220605 | Venus Bulk Flow ONE | Kulzer, LLC | 2022 | — |
| +1 | K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Kulzer, LLC | 2026 | — |
| +2 | K250267 | Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g… | Kettenbach GmbH & Co. KG | 2025 | — |
| +1 | K141994 | Bulk Fill Flowable Composite | Novocol, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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?
The FDA summary names no predicate by 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, K220605 (Kulzer, LLC, 2022) has gone furthest, with 2 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. 2009, 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?
Enlarged fissure sealing
Cavity lining - as the first layer for Class I and II cavities
Class V fillings
Minimally invasive Class I and II fillings in areas not subjected to masticatory forces
Minimally invasive Class III fillings
Small repairs of direct and indirect restorations combined with a suitable bonding agent
Interlocking of loosened teeth
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091635 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091635: Venus Diamond Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091635
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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