FDA-Device2019-10-09Class II
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - 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.).
Voco GmbH
Hazard
The metal cannula are potentially too loose and may become loose when applying the filing material.
Sold states
Distributed in the US to Iowa and New York
Affected count
5 units
Manufactured in
Anton-Flettner-Str. 1-3, N/A, Cuxhaven, N/A, Germany
Products
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - 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.).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0028-2020Don't want to check this manually?
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