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510(k) Data Aggregation

    K Number
    K232063
    Device Name
    SaliPen
    Manufacturer
    Date Cleared
    2023-12-13

    (155 days)

    Product Code
    Regulation Number
    872.5560
    Why did this record match?
    Product Code :

    QTT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SaliPen is an electrical salivary stimulator system, indicated for use in patients with xerostomia (dry mouth).
    Device Description
    SaliPen is an electrical salivary stimulatory system device. It is comprised of two units: an intraoral stimulating unit and an extra-oral command unit. The latter includes an electronic circuit, a compartment containing a 3V coin battery, and a bottom for switching the stimulation "On" and "Off". The stimulating unit is made of silicone rubber and includes a stem and two flexible arms. The stem is used to hold SaliPen between the lips. The flexible arms are shaped to the inner contour of the lower dental arch. Each arm carries one pair of stimulating electrodes. The device is designed in a manner that allows placing the electrodes on the linqual mucosa in the mandibular third molar region. Electrical stimulation is achieved by the delivery of low-power, low voltage, biphasic electrical pulses.
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    K Number
    K220618
    Device Name
    SaliPen
    Manufacturer
    Date Cleared
    2022-08-30

    (180 days)

    Product Code
    Regulation Number
    872.5560
    Why did this record match?
    Product Code :

    QTT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SaliPen is an electrical salivary stimulator system, indicated for use in patients with xerostomia (dry mouth).
    Device Description
    SaliPen is an electrical salivary stimulatory system device. It is comprised of two units: an intraoral stimulating unit and an extra-oral command unit. The latter includes an electronic circuit, a compartment containing a 3V coin battery, and a bottom for switching the stimulation "On" and "Off". The stimulating unit is made of silicone rubber and includes a stem and two flexible arms. The stem is used to hold SaliPen between the lips. The flexible arms are shaped to the inner contour of the lower dental arch. Each arm carries one pair of gold-plated stimulating electrodes. The device is designed in a manner that allows placing the electrodes on the lingual mucosa in the mandibular third molar region. The lingual nerve, which runs closely to this location, is the target of the stimulation due to its crucial role in the salivary reflex. Electrical stimulation is achieved by the delivery of low-power, low voltage, biphasic electrical pulses. The selected stimulating parameters provide effective stimulation, yet are well below the sensation thresholds, and definitely below the pain threshold. The user turns the device "On" and afterwards places the device in his/her mouth. After up to five minutes of use, the user removes the device from his/her mouth and deactivates the stimulation. The device is used not more than 5 times per day. The device and replacement devices are allowed for a cumulative use of up to 50 months.
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