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

    REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC.

    K Number: K963747 · Decision Dec 16, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    125
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC.
    K Number
    K963747
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6650
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Whitehill Manufacturing, Inc.
    Date Received
    September 17, 1996
    Decision Date
    December 16, 1996
    Product Code
    JET
    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
    JET Pick, Massaging

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