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

    ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+

    K Number: K863176 · Decision Nov 26, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    229
    Applicant Total
    7
    Review Days
    100

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    Basic Information

    Device Name
    ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+
    K Number
    K863176
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Coors Biomedical Co.
    Date Received
    August 18, 1986
    Decision Date
    November 26, 1986
    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 Coors Biomedical Co.

    K Number Device Name
    K862324 OSTEOGRAF/AR AND OSTEOGRAF/AR+
    K862061 OSTEOGRAF/AR+ PERMARIDGE HYDROXYLAPATITE, 18-40
    K861084 OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH
    K861083 OSTEOGRAF/AR+(PLUS) ALVEOLAR RID HYDROX 18-40 MESH
    K852742 OSTEOGRAF AR ALVEOLAR RIDGE HYDROXYLAPATITE 18-40
    K810822 DENTAL PORCELAIN POWDER