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510(k) Data Aggregation

    K Number
    K062344
    Device Name
    GRANDIO SEAL
    Manufacturer
    VOCO GMBH
    Date Cleared
    2006-10-02

    (52 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Type
    Abbreviated
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GRANDIO SEAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Grandio Seal is intended for sealing/filling of pits and fissures, sealing/facing of damaged enamel surfaces, covering of caries predilection sites during or damaged composite or coment fillings (redilection sites during orthodontic treatment, sealing of composite or cement filling of cance production sites uning of modeling of decident, sealing of deciduous teeth.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or any study details for the Grandio Seal device. The document is an FDA 510(k) clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device. It does not include performance data or clinical study results.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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