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

    DENTAL PROPHY CUPS (VARIOUS TYPES)

    K Number: K864059 · Decision Nov 19, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    116
    Registration Numbers
    116
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    30

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    Basic Information

    Device Name
    DENTAL PROPHY CUPS (VARIOUS TYPES)
    K Number
    K864059
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6290
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Mission White Dental, Inc.
    Date Received
    October 20, 1986
    Decision Date
    November 19, 1986
    Product Code
    EHK
    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
    EHK Cup, Prophylaxis

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