# K103580: Grandio SO Flow

- Pathway: 510(k) (Special)
- Applicant: Voco GmbH
- Decided: Jan 21, 2011 after 46 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
Grandio SO Flow is intended for use as: - filling minimally invasive cavities of all classes - filling small class I cavities and extended fissure sealing - filling class II-V cavities including V-shaped defects and cervical caries - blocking out undercuts - lining or coating cavities - repairing fillings and veneers - luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.)

Source page: https://510kreport.com/device/K103580
Methodology: https://510kreport.com/methodology