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

    MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM

    K Number: K021833 · Decision Jun 10, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    5
    Review Days
    6

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    Basic Information

    Device Name
    MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM
    K Number
    K021833
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Blue Sky Bio
    Date Received
    June 4, 2002
    Decision Date
    June 10, 2002
    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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