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    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇹 Italy

    ATR TECNIKA

    K Number: K000547 · Decision May 3, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    2
    Review Days
    75

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    Basic Information

    Device Name
    ATR TECNIKA
    K Number
    K000547
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Technology Research (A.T.R.) S.R.P.
    Date Received
    February 18, 2000
    Decision Date
    May 3, 2000
    Product Code
    EFB
    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
    EFB Handpiece, Air-Powered, Dental

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    Other Clearances by Advanced Technology Research (A.T.R.) S.R.P.

    K Number Device Name
    K991401 ATR 3000, ATR 2000, IMPLANT-PRO