BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    ID LIGHT CURE SYSTEM

    K Number: K250804 · Decision Jun 4, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    51
    Applicant Total
    1
    Review Days
    79

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    Basic Information

    Device Name
    ID LIGHT CURE SYSTEM
    K Number
    K250804
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3310
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Id Korea Co., Ltd.
    Date Received
    March 17, 2025
    Decision Date
    June 4, 2025
    Product Code
    EBD
    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
    EBD Coating, Filling Material, Resin

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