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

    KLS Martin IPS Preprosthetic

    K Number: K210228 · Decision Jul 8, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    58
    Review Days
    526

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    Basic Information

    Device Name
    KLS Martin IPS Preprosthetic
    K Number
    K210228
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3645
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KLS-Martin L.P.
    Date Received
    January 28, 2021
    Decision Date
    July 8, 2022
    Product Code
    ELE
    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
    ELE Implant, Subperiosteal

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