BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇩🇪 Germany

    T1/T2/T3 TURBINE FAMILY

    K Number: K131319 · Decision May 30, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    42
    Review Days
    388

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    Basic Information

    Device Name
    T1/T2/T3 TURBINE FAMILY
    K Number
    K131319
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sirona Dental Systems GmbH
    Date Received
    May 7, 2013
    Decision Date
    May 30, 2014
    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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    K150217 ORTHOPHOS SL
    K132773 SIDEXIS 4
    K123664 INCORIS ZI
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