# K220605: Venus Bulk Flow ONE

- Pathway: 510(k) (Special)
- Applicant: Kulzer, LLC
- Decided: Apr 21, 2022 after 50 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
Longest line of descent: 1 generation back to K091635 (2009). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091635: Venus Diamond Flow, Heraeus Kulzer, LLC (2009) Summary page 4.

## Most influential descendants
- 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

## Indications for use
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

Source page: https://510kreport.com/device/K220605
Methodology: https://510kreport.com/methodology