BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    DentaTOOTH

    K Number: K243370 · Decision May 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    180
    Registration Numbers
    180
    Same Product Code
    188
    Applicant Total
    2
    Review Days
    187

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    Basic Information

    Device Name
    DentaTOOTH
    K Number
    K243370
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3770
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Asiga Pty, Ltd.
    Date Received
    October 30, 2024
    Decision Date
    May 5, 2025
    Product Code
    EBG
    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
    EBG Crown And Bridge, Temporary, Resin

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    Other Clearances by Asiga Pty, Ltd.

    K Number Device Name
    K243356 Asiga DentaBASE