# K102351: Grandio SO

- Pathway: 510(k) (Special)
- Applicant: Voco GmbH
- Decided: Nov 2, 2010 after 75 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 K051867 (2005). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051867: Grandio, Voco GmbH (2005) Summary page 1.

## Most influential descendants
- K190139: Zircos-Com (2020), 0 descendants of its own

## Indications for use
Grandlo SO is intended for use as: - class I to V fillings - reconstruction of traumatically affected anteriors - facetting of discolored anteriors - correction of shape and shade for improved aesthetic appearance - locking, splinting of loose anteriors - repairing veneers - restoration of deciduous teeth - core-build-up under crowns - composite inlays

Source page: https://510kreport.com/device/K102351
Methodology: https://510kreport.com/methodology