K180680 is an FDA 510(k) clearance for the Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray. This device is classified as a Saliva, Artificial.
Submitted by Laclede, Inc. (Rancho Dominguez, US). The FDA issued a Cleared decision on October 11, 2018, 210 days after receiving the submission on March 15, 2018.
This device falls under the Dental FDA review panel.
| 510(k) Number | K180680 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 2018 |
| Decision Date | October 11, 2018 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LFD - Saliva, Artificial |
| Device Class | - |