K232063 is an FDA 510(k) clearance for the SaliPen. This device is classified as a Over The Counter Electrical Salivary Stimulatory System (Class II - Special Controls, product code QTT).
Submitted by Saliwell , Ltd. (Harutzim, IL). The FDA issued a Cleared decision on December 13, 2023, 155 days after receiving the submission on July 11, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5560. Over The Counter Device Intended To Electrically Stimulate A Relative Increase In Saliva Production.
| 510(k) Number | K232063 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2023 |
| Decision Date | December 13, 2023 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | QTT - Over The Counter Electrical Salivary Stimulatory System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5560 |
| Definition | Over The Counter Device Intended To Electrically Stimulate A Relative Increase In Saliva Production |