K193409 is an FDA 510(k) clearance for the Vista Rinse, Vista Rinse Plus. This device is classified as a Cleanser, Root Canal.
Submitted by Inter-Med/Vista Dental Products (Racine, US). The FDA issued a Cleared decision on September 9, 2020, 275 days after receiving the submission on December 9, 2019.
This device falls under the Dental FDA review panel.
| 510(k) Number | K193409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2019 |
| Decision Date | September 09, 2020 |
| Days to Decision | 275 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KJJ - Cleanser, Root Canal |
| Device Class | - |