QTT
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Over The Counter Electrical Salivary Stimulatory System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.5560
- Medical specialty
- Dental
- FDA definition
- Over the Counter Device intended to electrically stimulate a relative increase in saliva production
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SaliPen (K232063) | Saliwell , Ltd. | 2023-12-13 |
| SaliPen (K220618) | Saliwell , Ltd. | 2022-08-30 |
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Every clearance here is in the API, with alerts when new ones post.