BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS)

    K Number: K042345 · Decision Jan 13, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    6
    Review Days
    136

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    Basic Information

    Device Name
    LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS)
    K Number
    K042345
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mondeal Medical Systems GmbH
    Date Received
    August 30, 2004
    Decision Date
    January 13, 2005
    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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    Other Clearances by Mondeal Medical Systems GmbH

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