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

    DOCTOR KOLYNOS TOOTHBRUSH

    K Number: K882572 · Decision Apr 17, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    573
    Registration Numbers
    574
    Same Product Code
    48
    Applicant Total
    2
    Review Days
    299

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    Basic Information

    Device Name
    DOCTOR KOLYNOS TOOTHBRUSH
    K Number
    K882572
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6855
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Whitehall Laboratories, Inc.
    Date Received
    June 22, 1988
    Decision Date
    April 17, 1989
    Product Code
    EFW
    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
    EFW Toothbrush, Manual

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    Other Clearances by Whitehall Laboratories, Inc.

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    K882571 KOLYNOS DENTAL FLOSS