# K062344: Grandio Seal

- Pathway: 510(k) (Abbreviated)
- Applicant: Voco GmbH
- Decided: Oct 2, 2006 after 52 days
- Product code: EBC (Sealant, Pit And Fissure, And Conditioner)
- Device class: 2
- Regulation: 21 CFR 872.3765
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K091632: SPK Sealant (2009), 2 descendants of its own
- K100062: Infiltration Kit (2010), 1 descendant of its own
- K251124: G-Bond Universal (2025), 0 descendants of its own
- K081493: Infiltration Kit (2008), 0 descendants of its own

## Indications for use
Grandio Seal is intended for sealing/filling of pits and fissures, sealing/facing enamel surfaces, covering of caries predilection sites during orthodontic treatment, sealing of damaged composite or cement fillings (protective layer against moisture) and sealing of deciduous teeth.

Source page: https://510kreport.com/device/K062344
Methodology: https://510kreport.com/methodology