# K051867: Grandio

- Pathway: 510(k) (Special)
- Applicant: Voco GmbH
- Decided: Jul 27, 2005 after 16 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices 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.

## Most influential descendants
- K103190: Profil Composites (Profil, Profil Flow) (2011), 1 descendant of its own
- K102351: Grandio SO (2010), 1 descendant of its own
- K220077: IMICRYL Composite, Composite Flow Materials (2022), 0 descendants of its own
- K190139: Zircos-Com (2020), 0 descendants of its own
- K072150: Dimer Acid Derived Nano-Hybrid Composite Restorative Material (2007), 0 descendants of its own

## Recalls of this device
- Jul 9, 2026 · Class II · Z-3016-2026: Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.

## Indications for use
Fillings of class I-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 crowns Composite inlays

Source page: https://510kreport.com/device/K051867
Methodology: https://510kreport.com/methodology