Over The Counter Electrical Salivary Stimulatory System
The Over The Counter Electrical Salivary Stimulatory System is a consumer-accessible device intended to electrically stimulate an increase in saliva production, providing relief for patients suffering from dry mouth (xerostomia) without requiring a prescription. It delivers controlled electrical stimulation to salivary gland-related tissues. Classified as FDA Class 2 under regulation 872.5560, it requires 510(k) clearance in the Dental specialty. The device is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QTT
- Device Class
- FDA class 2
- Regulation Number
- 872.5560
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
Definition
Over the Counter Device intended to electrically stimulate a relative increase in saliva production
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.