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

    Transcend

    K Number: K201795 · Decision Sep 28, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    931
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    Transcend
    K Number
    K201795
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ultradent Product, Inc.
    Date Received
    June 30, 2020
    Decision Date
    September 28, 2020
    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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