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510(k) Data Aggregation
K Number
K232063Device Name
SaliPen
Manufacturer
Date Cleared
2023-12-13
(155 days)
Product Code
Regulation Number
872.5560Why did this record match?
Applicant Name (Manufacturer) :
Saliwell Ltd.
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
K220618Device Name
SaliPen
Manufacturer
Date Cleared
2022-08-30
(180 days)
Regulation Number
872.5560Why did this record match?
Applicant Name (Manufacturer) :
Saliwell Ltd.
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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K Number
K180838Device Name
SaliPen
Manufacturer
Date Cleared
2018-11-06
(221 days)
Product Code
Regulation Number
872.5560Why did this record match?
Applicant Name (Manufacturer) :
Saliwell Ltd.
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), under prescription of a dental practitioner or physician.
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 linqual mucosa in the mandibular third molar region. The linqual 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 on "as need" base (i.e., when the users feels oral dryness) but not more than 5 times per day. The device and replacement devices are allowed for a cumulative use of up to 50 months.
Clinical trials showed that electrical stimulation to the lingual mucosa in the mandibular third molar region increases relative saliva production, resulting in more oral lubrication, due to the mechanical and electrical stimulation (both well-known techniques to increase salivary secretion and to relieve symptoms of dry mouth).
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K Number
K160799Device Name
GenNarino
Manufacturer
Date Cleared
2017-02-17
(331 days)
Product Code
Regulation Number
872.5560Why did this record match?
Applicant Name (Manufacturer) :
SALIWELL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
GenNarino is an electrical salivary stimulator system, indicated for use in patients with xerostomia (dry mouth), under prescription of a dental practitioner or physician.
Device Description
GenNarino is an electrical salivary system device. It is comprised of two units: a mouthpiece shaped to the contour of the lower dental arch and an infra-red remote control to turn the stimulation On or Off. The mouthpiece comprises of two dental grade plastic sheets. GenNarino embed an electronic module hermetically sealed between both sheets and a power source of two 3V small coin batteries. Two electrodes made of biocompatible materials are connected to the electronic module, protrude from the plastic sheet and contact the mucosa of the lower dental arch, at the lingual side. The electronic circuit allows switching the stimulation "On" and "Off" by an external remote control. The user pushes the remote control's "ON" button to turn the electronic circuit on and afterwards places the device on his/her lower dental arch. Typically after up to five minutes of use, the user removes the device from his/her mouth and deactivates the stimulation by pushing the remote control's "OFF" button. The device is used on "as need" base (i.e. when the users feels oral dryness) but 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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