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

    DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE

    K Number: K030980 · Decision Aug 25, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    192
    Applicant Total
    7
    Review Days
    150

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    Basic Information

    Device Name
    DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE
    K Number
    K030980
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3750
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dentaurum
    Date Received
    March 28, 2003
    Decision Date
    August 25, 2003
    Product Code
    DYH
    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
    DYH Adhesive, Bracket And Tooth Conditioner, Resin

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    Other Clearances by Dentaurum

    K Number Device Name
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    K062732 TOMAS PIN 6 MM
    K030644 CONTEC DUO, CONTEC LC, CONTEC LCR
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    K030641 CONTEC LIGHT