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510(k) Data Aggregation

    K Number
    K220236
    Device Name
    V-Print dentbase
    Manufacturer
    Voco GmbH
    Date Cleared
    2022-09-21

    (237 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Removable denture bases

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for a dental device (V-Print dentbase) and outlines regulatory information and indications for use. It does not provide details about specific acceptance criteria for a study, performance metrics, sample sizes, expert qualifications, or study methodologies.

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