SaliPen
by Saliwell, Ltd. 510(k)
Active
510(k) K220618
Overview
The SaliPen is an Over-The-Counter Electrical Salivary Stimulatory System, classified as a Class 2 Dental device. It is designed to stimulate salivary gland function, promoting saliva production to alleviate symptoms of xerostomia (dry mouth). This device operates via gentle electrical stimulation, targeting the salivary glands to encourage natural saliva flow without pharmacological intervention. Its primary purpose is to provide relief from discomfort associated with reduced saliva production, including difficulties in speaking, swallowing, and increased dental decay risk.
The SaliPen is supplied as a single-use or reusable device, depending on manufacturer guidelines, and is intended for home or clinical use. It is not sterile and requires proper cleaning and maintenance as instructed by the manufacturer. The device is FDA-cleared under 510(k) number K220618, with a product code of QTT, and falls under regulation number 872.5560. Storage conditions and MRI safety are not specified in the available data, but adherence to manufacturer instructions is essential for optimal performance and safety.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK220618 | Date30 Aug 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- QTT
- FDA applicant
- Saliwell , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.5560
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Saliwell, Ltd.
Questions
What is the SaliPen designed to treat?
The SaliPen is an Over-The-Counter Electrical Salivary Stimulatory System intended to alleviate symptoms of xerostomia (dry mouth). It works by delivering gentle electrical stimulation to the salivary glands, encouraging natural saliva production. This helps relieve discomfort like difficulty speaking, swallowing, and reduces the risk of dental decay associated with reduced saliva flow.
Is the SaliPen single-use or reusable?
The SaliPen can be used either as a single-use or reusable device, depending on the manufacturer’s guidelines. If reused, it requires proper cleaning and maintenance as instructed to ensure safety and effectiveness. Always follow the manufacturer’s instructions to avoid contamination or damage.
Does the SaliPen require sterilization before use?
No, the SaliPen is not sterile and should not be considered for sterile procedures. It is designed for home or clinical use where sterility is not required. Proper cleaning and maintenance are necessary to prevent bacterial buildup, especially if reused.
What are the key differences between the SaliPen and other salivary stimulators?
The SaliPen distinguishes itself by using gentle electrical stimulation to encourage natural saliva production without pharmacological intervention. Unlike some alternatives that may rely on oral rinses or pills, it targets the salivary glands directly. Its FDA clearance under 510(k) number K220618 also ensures it meets regulatory standards for safety and effectiveness as a Class 2 dental device.
How should the SaliPen be stored?
While specific storage conditions like temperature or humidity are not detailed in the available data, the manufacturer’s instructions should be followed to maintain optimal performance. Avoid exposing the device to extreme conditions, moisture, or physical damage. If stored long-term, ensure it is clean and dry to prevent bacterial growth, particularly if reused.