K231205 is an FDA 510(k) clearance for the GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray. This device is classified as a Saliva, Artificial.
Submitted by Gurunanda, LLC (Buena Park, US). The FDA issued a Cleared decision on August 22, 2023, 117 days after receiving the submission on April 27, 2023.
This device falls under the Dental FDA review panel.
| 510(k) Number | K231205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2023 |
| Decision Date | August 22, 2023 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LFD - Saliva, Artificial |
| Device Class | - |