BEUDAMED
    Product Code: MCL FDA class 3

    Kit, Test, In Vitro Periodontal

    Unknown

    The in vitro periodontal test kit is a diagnostic device intended to assess periodontal disease status through laboratory analysis of biological markers in gingival crevicular fluid or other oral specimens. It is classified as FDA Class III, requiring Premarket Approval (PMA) with clinical evidence of safety and effectiveness. The product code is MCL and no regulation number or formal medical specialty has been assigned. The device is not an implant and does not sustain life.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    MCL
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    DE
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
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    Summary Malfunction Reporting