# K091635: Venus Diamond Flow

- Pathway: 510(k) (Abbreviated)
- Applicant: Heraeus Kulzer, LLC
- Decided: Sep 3, 2009 after 91 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K220605: Venus Bulk Flow ONE (2022), 2 descendants of its own
- K260783: Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One (2026), 0 descendants of its own
- K250267: Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068) (2025), 0 descendants of its own
- K141994: Bulk Fill Flowable Composite (2014), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K091635
Methodology: https://510kreport.com/methodology