# K030915: Grandio

- Pathway: 510(k) (Traditional)
- Applicant: Voco GmbH
- Decided: May 30, 2003 after 67 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
Fillings of class I to V Reconstruction of traumatically affected anteriors Facetting of discolored anteriors Correction of shape and shade for better aesthetic appearance Locking, splinting of loose anteriors Repair of veneers Filling of deciduous teeth Core-build-up under crowiis Composite inlays

Source page: https://510kreport.com/device/K030915
Methodology: https://510kreport.com/methodology