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

    DENTAL UNIT WITH CHAIR

    K Number: K080438 · Decision Apr 4, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    111
    Same Product Code
    283
    Applicant Total
    2
    Review Days
    45

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    Basic Information

    Device Name
    DENTAL UNIT WITH CHAIR
    K Number
    K080438
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    North West Medical Instrument (Group) Co., Ltd.
    Date Received
    February 19, 2008
    Decision Date
    April 4, 2008
    Product Code
    EIA
    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
    EIA Unit, Operative Dental

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

    K Number Device Name
    K093971 DENTAL HANDPIECE