# K033665: Venus Flow

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: Dec 30, 2003 after 39 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Venus flow is a flowable, light curing, radiopaque hyrbrid composite used for adhesive, tooth-colored anterior and posterior restorations. Due to its low viscosity Venus Flow provides excellent coverage tooth structure. Applicable applications includes: Baseliner in Class I & II cavities; Fissure sealing; Enlarged fissure sealing; Class V fillings; Minimally invasive Class I and II fillings in areas not subjected to masticatory forces; Minimally invasive Class III fillings; Smaller contour and shade adjustment on the enamel and dentine; Small surface repairs to direct and indirect restorative in combination with a suitable bonding agent; Splinting teeth; Cavity lining; Bracket retention; Sealing endodontically treated teeth; Luting porcelain or composite veneers; Filling in voids in temporary crown and bridges materials

Source page: https://510kreport.com/device/K033665
Methodology: https://510kreport.com/methodology