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

    OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH

    K Number: K861084 · Decision Apr 30, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    229
    Applicant Total
    7
    Review Days
    40

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    Basic Information

    Device Name
    OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH
    K Number
    K861084
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Coors Biomedical Co.
    Date Received
    March 21, 1986
    Decision Date
    April 30, 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
    K863176 ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+
    K862324 OSTEOGRAF/AR AND OSTEOGRAF/AR+
    K862061 OSTEOGRAF/AR+ PERMARIDGE HYDROXYLAPATITE, 18-40
    K861083 OSTEOGRAF/AR+(PLUS) ALVEOLAR RID HYDROX 18-40 MESH
    K852742 OSTEOGRAF AR ALVEOLAR RIDGE HYDROXYLAPATITE 18-40
    K810822 DENTAL PORCELAIN POWDER