QTT
- Product code
- QTT
- Device name
- Over The Counter Electrical Salivary Stimulatory System
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.5560
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 0 (direct download)
- 510(k) clearances (all years, FDA)
- 2 (all years; only the last 3 years are listed here)
FDA classification definition
Over the Counter Device intended to electrically stimulate a relative increase in saliva production
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K232063 | 2023-12-13 | Saliwell , Ltd. | SaliPen | FDA |
Official FDA classification page: QTT
Classification and pathway per current FDA publications. Data from openFDA (CC0).