BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇰🇷 South Korea

    TRAUS SIP10

    K Number: K123695 · Decision Dec 18, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    18
    Review Days
    15

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    Basic Information

    Device Name
    TRAUS SIP10
    K Number
    K123695
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Saeshin Precision Co., Ltd.
    Date Received
    December 3, 2012
    Decision Date
    December 18, 2012
    Product Code
    EKY
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EKY Handpiece, Water-Powered

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