510(k) · Cleared
ClearedVenus Bulk Flow ONE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kulzer, LLC · EBF Material, Tooth Shade, Resin
Cleared on Apr 21, 2022 as substantially equivalent to K091635 (Heraeus Kulzer, LLC, 2009) after a 50-day review. Its family tree reaches back 1 generation to 2009. 2 later devices descend from it.
- Decided
- Apr 21, 2022
- Review
- 50 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K091635 (2009). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK091635 Venus Diamond FlowHeraeus Kulzer, LLC · 2009
- This deviceK220605 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 · cites it directly · 0 of its ownK250267 Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x…Kettenbach GmbH & Co. KG · 2025
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 |
|---|---|---|---|---|---|
| −1 | K091635 | Venus Diamond Flow | Heraeus Kulzer, LLC | 2009 | — |
| 0 (this device) | K220605 | Venus Bulk Flow ONE | Kulzer, LLC | 2022 | — |
| +1 | K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Kulzer, LLC | 2026 | — |
| +1 | K250267 | Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g… | Kettenbach GmbH & Co. KG | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K091635 | Venus Diamond FlowSummary page 4…t Code: 76 E BF Classification Name (21 CFR 872.3690): Material, Tooth Shade Resin 807.92(a)3 Legally marketed device of which equivalence is claimed: VenusDiamond Flow (K091635) [807.92(a)(4)] Description of Device: Venus Bulk Flow ONE is a light curing, radio-opaque nano-hybrid composite. The uncured den… | 2009 |
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?
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Extended fissure sealing
First-layer lining for class I and class II cavities
Class I, II, III and V direct restorations
Repair of direct and indirect restorations in combination with a suitable adhesive
Splinting loosened teeth resulting from trauma or periodontal associated events
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220605 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220605: Venus Bulk Flow ONE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220605
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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