BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CHALLENGE-EVER

    K Number: K102223 · Decision Feb 25, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    111
    Same Product Code
    283
    Applicant Total
    1
    Review Days
    203

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    Basic Information

    Device Name
    CHALLENGE-EVER
    K Number
    K102223
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hallim Dentech Co., Ltd.
    Date Received
    August 6, 2010
    Decision Date
    February 25, 2011
    Product Code
    EIA
    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
    EIA Unit, Operative Dental

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