Stimulator, Salivary System
The Salivary System Stimulator is a dental device designed to stimulate salivary gland function and increase salivary flow, used in the management of xerostomia (dry mouth) in patients with salivary gland hypofunction due to radiation therapy, medication side effects, or systemic conditions. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification. The product code is LTF, regulated under 21 CFR 872.5560, within the Dental medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LTF
- Device Class
- FDA class 2
- Regulation Number
- 872.5560
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
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.