Submission Details
| 510(k) Number | K152406 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 25, 2015 |
| Decision Date | December 23, 2015 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
K152406 is an FDA 510(k) clearance for the SalivaMAX. This device is classified as a Saliva, Artificial.
Submitted by Forward Science, LLC (Stafford, US). The FDA issued a Cleared decision on December 23, 2015, 120 days after receiving the submission on August 25, 2015.
This device falls under the Dental FDA review panel.
| 510(k) Number | K152406 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 25, 2015 |
| Decision Date | December 23, 2015 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LFD — Saliva, Artificial |
| Device Class | — |