BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Bifix Veneer LC, Bifix Veneer Try-In

    K Number: K252606 · Decision Mar 20, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    504
    Applicant Total
    119
    Review Days
    214

    Basic Information

    Device Name
    Bifix Veneer LC, Bifix Veneer Try-In
    K Number
    K252606
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Voco GmbH
    Date Received
    August 18, 2025
    Decision Date
    March 20, 2026
    Product Code
    EMA
    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
    EMA Cement, Dental

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