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

    TIA Tip, Cariosity, Transillumination Accessory Tip

    K Number: K213482 · Decision Apr 29, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    182

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    Basic Information

    Device Name
    TIA Tip, Cariosity, Transillumination Accessory Tip
    K Number
    K213482
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1745
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    D4D Technologies, LLC
    Date Received
    October 29, 2021
    Decision Date
    April 29, 2022
    Product Code
    NTK
    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
    NTK Caries Detector, Laser Light, Transmission

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