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

    ULTRA-LITE 5 TURBO LIGHT CURE UNIT

    K Number: K020874 · Decision Jun 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    211
    Applicant Total
    5
    Review Days
    86

    Basic Information

    Device Name
    ULTRA-LITE 5 TURBO LIGHT CURE UNIT
    K Number
    K020874
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6070
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    ROLENCE ENT. INC.
    Date Received
    March 18, 2002
    Decision Date
    June 12, 2002
    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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