BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇯🇵 Japan

    ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE

    K Number: K113222 · Decision Feb 23, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    258
    Applicant Total
    1
    Review Days
    114

    Basic Information

    Device Name
    ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE
    K Number
    K113222
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    NAKAMURA DENTAL HANDPIECE MFG. CO., LTD.
    Date Received
    November 1, 2011
    Decision Date
    February 23, 2012
    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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