FDA Product Code QTT: Over The Counter Electrical Salivary Stimulatory System
Over The Counter Device Intended To Electrically Stimulate A Relative Increase In Saliva Production
Leading manufacturers include Saliwell , Ltd..
2
Total
2
Cleared
168d
Avg days
2022
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Over The Counter Electrical Salivary Stimulatory System Devices (Product Code QTT)
2 devices
Cleared
Dec 13, 2023
SaliPen
Saliwell , Ltd.
Dental
155d
Cleared
Aug 30, 2022
SaliPen
Saliwell , Ltd.
Dental
180d
About Product Code QTT - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QTT since 2022, with 2 receiving FDA clearance (average review time: 168 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
QTT devices are reviewed by the Dental panel. Browse all Dental devices →