BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HANDPIECE MODELS MS-350, RS-350; AIR MOTOR N-270

    K Number: K922437 · Decision Dec 21, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    4
    Review Days
    213

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    Basic Information

    Device Name
    HANDPIECE MODELS MS-350, RS-350; AIR MOTOR N-270
    K Number
    K922437
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dabi-Atlante America Corp.
    Date Received
    May 22, 1992
    Decision Date
    December 21, 1992
    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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    Other Clearances by Dabi-Atlante America Corp.

    K Number Device Name
    K926155 CA AND ST
    K926154 HANDPIECE MODELS: MS-350;RS-350;N-270 AIR-MOTOR
    K912997 MINIFLEX AND PERSONAL UNIT