BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Q-LITE 75 LIGHT CURE UNIT

    K Number: K991865 · Decision Jul 20, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    213
    Applicant Total
    12
    Review Days
    49

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    Basic Information

    Device Name
    Q-LITE 75 LIGHT CURE UNIT
    K Number
    K991865
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6070
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rolence Enterprise Co. , Ltd.
    Date Received
    June 1, 1999
    Decision Date
    July 20, 1999
    Product Code
    EBZ
    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
    EBZ Activator, Ultraviolet, For Polymerization

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