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

    PROSTHETICS 4MM

    K Number: K952992 · Decision Oct 31, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    333
    Registration Numbers
    333
    Same Product Code
    1516
    Applicant Total
    20
    Review Days
    130

    Basic Information

    Device Name
    PROSTHETICS 4MM
    K Number
    K952992
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    IMPLANT CENTER OF THE PALM BEACHES
    Date Received
    June 23, 1995
    Decision Date
    October 31, 1995
    Product Code
    DZE
    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
    DZE Implant, Endosseous, Root-Form

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