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

    IMPRESSION TRAY

    K Number: K780678 · Decision Apr 28, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    317
    Registration Numbers
    317
    Same Product Code
    15
    Applicant Total
    6
    Review Days
    4

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    Basic Information

    Device Name
    IMPRESSION TRAY
    K Number
    K780678
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6880
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Rocky Mountain Orthodontics, Inc.
    Date Received
    April 24, 1978
    Decision Date
    April 28, 1978
    Product Code
    EHY
    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
    EHY Tray, Impression, Preformed

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