BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DentMix VPS Impression Material

    K Number: K223892 · Decision Apr 27, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    399
    Applicant Total
    2
    Review Days
    120

    Basic Information

    Device Name
    DentMix VPS Impression Material
    K Number
    K223892
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Innovative Product Brands, Inc.
    Date Received
    December 28, 2022
    Decision Date
    April 27, 2023
    Product Code
    ELW
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ELW Material, Impression

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