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

    MedCAD® AccuPlate® Patient-Specific Plate

    K Number: K193280 · Decision Feb 12, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    291
    Applicant Total
    9
    Review Days
    443

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    Basic Information

    Device Name
    MedCAD® AccuPlate® Patient-Specific Plate
    K Number
    K193280
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medcad
    Date Received
    November 27, 2019
    Decision Date
    February 12, 2021
    Product Code
    JEY
    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
    JEY Plate, Bone

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