BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ORTHODONTIC ARCH

    K Number: K872622 · Decision Oct 9, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    95

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    Basic Information

    Device Name
    ORTHODONTIC ARCH
    K Number
    K872622
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Wonder Wire
    Date Received
    July 6, 1987
    Decision Date
    October 9, 1987
    Product Code
    EJZ
    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
    EJZ Knife, Margin Finishing, Operative

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EJZ), ordered by most recent decision date.

    DENTAL INSTRUMENTS - KNIVES

    FDA 510(k)
    FDA Class 1 ·Dental
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    K Number Device Name
    K931631 COATED ORTHODONTIC DEVICES