BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    RAPID IMF

    K Number: K030605 · Decision Jun 27, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    122

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    Basic Information

    Device Name
    RAPID IMF
    K Number
    K030605
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4600
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Zygomatics , Ltd.
    Date Received
    February 25, 2003
    Decision Date
    June 27, 2003
    Product Code
    DYX
    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
    DYX Lock, Wire, And Ligature, Intraoral

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