BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇦🇹 Austria

    IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)

    K Number: K002469 · Decision Feb 7, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    60
    Applicant Total
    18
    Review Days
    180

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    Basic Information

    Device Name
    IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)
    K Number
    K002469
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    W&H Dentalwerk Buermoos GmbH
    Date Received
    August 11, 2000
    Decision Date
    February 7, 2001
    Product Code
    EBW
    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
    EBW Controller, Foot, Handpiece And Cord

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