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

    FLOSS HOLDER (PLASTIC)

    K Number: K855113 · Decision Mar 6, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    335
    Registration Numbers
    336
    Same Product Code
    61
    Applicant Total
    5
    Review Days
    73

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    Basic Information

    Device Name
    FLOSS HOLDER (PLASTIC)
    K Number
    K855113
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6390
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Pacific Union Dental, Inc.
    Date Received
    December 23, 1985
    Decision Date
    March 6, 1986
    Product Code
    JES
    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
    JES Floss, Dental

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