BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇴 Colombia

    ZAFIRA®

    K Number: K254245 · Decision Mar 3, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    931
    Applicant Total
    2
    Review Days
    64

    Basic Information

    Device Name
    ZAFIRA®
    K Number
    K254245
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    New Stetic, SA
    Date Received
    December 29, 2025
    Decision Date
    March 3, 2026
    Product Code
    EBF
    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
    EBF Material, Tooth Shade, Resin

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