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

    FLEXI-POST

    K Number: K843018 · Decision Sep 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    2
    Applicant Total
    17
    Review Days
    57

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    Basic Information

    Device Name
    FLEXI-POST
    K Number
    K843018
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Essential Dental Systems, Inc.
    Date Received
    August 1, 1984
    Decision Date
    September 27, 1984
    Product Code
    ECR
    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
    ECR Setter, Band, Orthodontic

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