# K102354: Grandio SO Heavy Flow

- Pathway: 510(k) (Special)
- Applicant: Voco GmbH
- Decided: Nov 8, 2010 after 81 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K051868 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051868: Grandio Flow, Voco GmbH (2005) Summary page 1.
- K101213: Grandio Flow, Voco GmbH (2010) Summary page 1.

## Recalls of this device
- Jul 9, 2019 · Class II · Z-0028-2020: The metal cannula are potentially too loose and may become loose when applying the filing material.

## Indications for use
Grandia SO Heavy Flow is intended for use as: - filling minimally invasive cavities of all classes - filling small class I cavities and extended fissure sealing - filling class 11- 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/K102354
Methodology: https://510kreport.com/methodology