Product Code: LTF FDA class 2 21 CFR 872.5560

Stimulator, Salivary System

Dental

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.

510(k)s
2
FEI Numbers
1
Registration Numbers
1
Unique Applicants
1
Years Active
2

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K180838 SaliPen
K160799 GenNarino

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.