BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇳 China

    DENTAL HANDPIECE

    K Number: K093971 · Decision Apr 22, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    2
    Review Days
    119

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    Basic Information

    Device Name
    DENTAL HANDPIECE
    K Number
    K093971
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    North West Medical Instrument (Group) Co., Ltd.
    Date Received
    December 24, 2009
    Decision Date
    April 22, 2010
    Product Code
    EFB
    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
    EFB Handpiece, Air-Powered, Dental

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    Other Clearances by North West Medical Instrument (Group) Co., Ltd.

    K Number Device Name
    K080438 DENTAL UNIT WITH CHAIR