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

    SOPHOS DENTAL DIAMOND

    K Number: K943841 · Decision Sep 16, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    20
    Applicant Total
    1
    Review Days
    42

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    Basic Information

    Device Name
    SOPHOS DENTAL DIAMOND
    K Number
    K943841
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4535
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sophos Technologic
    Date Received
    August 5, 1994
    Decision Date
    September 16, 1994
    Product Code
    DZP
    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
    DZP Instrument, Diamond, Dental

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