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

    REPLAM HYDROXYAPATITE

    K Number: K830304 · Decision Apr 6, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    229
    Applicant Total
    2
    Review Days
    68

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    Basic Information

    Device Name
    REPLAM HYDROXYAPATITE
    K Number
    K830304
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Replam Corp.
    Date Received
    January 28, 1983
    Decision Date
    April 6, 1983
    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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    Other Clearances by Replam Corp.

    K Number Device Name
    K822420 REPLAM HYDROXYAPATATITE