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

    DEN-Z-ORB

    K Number: K780400 · Decision Mar 27, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    148
    Registration Numbers
    148
    Same Product Code
    9
    Applicant Total
    9
    Review Days
    14

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    Basic Information

    Device Name
    DEN-Z-ORB
    K Number
    K780400
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6050
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Nice-Pak Products, Inc.
    Date Received
    March 13, 1978
    Decision Date
    March 27, 1978
    Product Code
    KHR
    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
    KHR Absorber, Saliva, Paper

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