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

    LED Curing Light

    K Number: K152192 · Decision Apr 7, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    213
    Applicant Total
    9
    Review Days
    611

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    Basic Information

    Device Name
    LED Curing Light
    K Number
    K152192
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6070
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Monitex Industrial Co., Ltd.
    Date Received
    August 5, 2015
    Decision Date
    April 7, 2017
    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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    Other Clearances by Monitex Industrial Co., Ltd.

    K Number Device Name
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    K080035 LED CURING LIGHT
    K060646 BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855
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