Submission Details
| 510(k) Number | K240508 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 21, 2024 |
| Decision Date | April 19, 2024 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
K240508 is an FDA 510(k) clearance for the Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel), a Saliva, Artificial, submitted by Laclede, Inc. (Rancho Dominguez, US). The FDA issued a Cleared decision on April 19, 2024, 58 days after receiving the submission on February 21, 2024. This device falls under the Dental review panel.
| 510(k) Number | K240508 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 21, 2024 |
| Decision Date | April 19, 2024 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LFD — Saliva, Artificial |
| Device Class | — |