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

    SYLVAN DENTAL HEADLIGHT SYSTEM

    K Number: K923949 · Decision Oct 16, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    72

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    Basic Information

    Device Name
    SYLVAN DENTAL HEADLIGHT SYSTEM
    K Number
    K923949
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sylvan Medical Fiberoptics
    Date Received
    August 5, 1992
    Decision Date
    October 16, 1992
    Product Code
    EBA
    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
    EBA Light, Surgical Headlight

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