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

    KLS-MARTIN TEMPORARY CONDYLAR IMPLANT

    K Number: K990667 · Decision Jul 27, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    6
    Applicant Total
    58
    Review Days
    878

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    Basic Information

    Device Name
    KLS-MARTIN TEMPORARY CONDYLAR IMPLANT
    K Number
    K990667
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4770
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KLS-Martin L.P.
    Date Received
    March 2, 1999
    Decision Date
    July 27, 2001
    Product Code
    NEI
    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
    NEI Prosthesis, Condyle, Mandibular, Temporary

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