# K260783: Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One

- Pathway: 510(k) (Traditional)
- Applicant: Kulzer, LLC
- Decided: Mar 11, 2026 after 1 day
- 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
Longest line of descent: 2 generations back to K083610 (2008). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073554: NEUN, Heraeus Kulzer,GmbH (2008) Summary page 9.
- K091635: Venus Diamond Flow, Heraeus Kulzer, LLC (2009) Summary page 9.
- K112501: Venus Pearl PLT Refill A1, Heraeus Kulzer, LLC (2011) Summary page 9.
- K220605: Venus Bulk Flow ONE, Kulzer, LLC (2022) Summary page 9.

## Indications for use
• Class I, II, III, IV and V direct restorations • First-layer lining for class I and II cavities • Repair of direct and indirect restorations in combination with a suitable adhesive • Splinting of teeth • Extended fissure sealing • Composite attachments for aligner treatment • Fixation of retainers * Enlarged fissure sealing * Cavity lining — as the first layer for Class I and II cavities e Class I, II, III, IV and V direct restorations * Small repairs of direct and indirect restorations combined with a suitable bonding agent * Splinting of teeth » Composite attachments for aligner treatment » Fixation of retainers * Direct restorations of all cavity classes * Direct composite veneers » Shape corrections of teeth (i.e. diastemas, congenital defects in teeth, etc.) * Splinting of teeth * Restoration of primary teeth * Core build-up * Repairs of porcelain, composite (in combination with an adequate repair-system) » Composite attachments for aligner treatment » Fixation of retainers * Direct restorations of all cavity classes * Direct composite veneers » Shape corrections of teeth (i.e. diastemas, congenital defects in teeth, etc.) * Splinting of teeth * Restoration of primary teeth * Core build-up * Repairs of porcelain, composite (in combination with an adequate repair-system) » Composite attachments for aligner treatment » Fixation of retainers

Source page: https://510kreport.com/device/K260783
Methodology: https://510kreport.com/methodology