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

    RIDGEMATRIX 20/40 MESH, PERIOMATRIX

    K Number: K842163 · Decision Aug 9, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    229
    Applicant Total
    8
    Review Days
    71

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    Basic Information

    Device Name
    RIDGEMATRIX 20/40 MESH, PERIOMATRIX
    K Number
    K842163
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Orthomatrix, Inc.
    Date Received
    May 30, 1984
    Decision Date
    August 9, 1984
    Product Code
    LYC
    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
    LYC Bone Grafting Material, Synthetic

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