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

    COOL TEMP NATURAL

    K Number: K041098 · Decision May 13, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    180
    Registration Numbers
    180
    Same Product Code
    188
    Applicant Total
    2
    Review Days
    16

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    Basic Information

    Device Name
    COOL TEMP NATURAL
    K Number
    K041098
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3770
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Coltene AG
    Date Received
    April 27, 2004
    Decision Date
    May 13, 2004
    Product Code
    EBG
    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
    EBG Crown And Bridge, Temporary, Resin

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    Other Clearances by Coltene AG

    K Number Device Name
    K022224 COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM