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

    K-APATITE 20-40 MESH K-APATITE 40-60

    K Number: K843557 · Decision Nov 30, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    26
    Review Days
    81

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    Basic Information

    Device Name
    K-APATITE 20-40 MESH K-APATITE 40-60
    K Number
    K843557
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3645
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Katecho, Inc.
    Date Received
    September 10, 1984
    Decision Date
    November 30, 1984
    Product Code
    ELE
    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
    ELE Implant, Subperiosteal

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    Other Clearances by Katecho, Inc.

    K Number Device Name
    K012404 K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
    K010543 KM-30 TENS ELECTRODE
    K003228 K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A
    K002806 K-DEFIB/PACE, MODEL KDP-60A
    K000870 KM-10 TENS ELECTRODE
    K993745 K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80
    K991007 K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60
    K981737 K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60
    K954504 K-DEFIB/PACE PEDIATRIC ELECTRODE
    K934692 K-DEFIB/PACE PEDIATRIC ELECTRODE
    Search all 26 clearances from Katecho, Inc. →