BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CALSET COMPOSITE HEATER

    K Number: K061395 · Decision Jun 23, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    213
    Applicant Total
    7
    Review Days
    35

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    Basic Information

    Device Name
    CALSET COMPOSITE HEATER
    K Number
    K061395
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6070
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Addent, Inc.
    Date Received
    May 19, 2006
    Decision Date
    June 23, 2006
    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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