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

    ORTHOMITE 111 ADHESIVE

    K Number: K843527 · Decision Oct 18, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    192
    Applicant Total
    6
    Review Days
    41

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    Basic Information

    Device Name
    ORTHOMITE 111 ADHESIVE
    K Number
    K843527
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3750
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Rocky Mountain Orthodontics, Inc.
    Date Received
    September 7, 1984
    Decision Date
    October 18, 1984
    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 Rocky Mountain Orthodontics, Inc.

    K Number Device Name
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