K211813 is an FDA 510(k) clearance for the Triton. This device is classified as a Cleanser, Root Canal.
Submitted by Inter-Med / Vista Dental (Racine, US). The FDA issued a Cleared decision on August 18, 2021, 68 days after receiving the submission on June 11, 2021.
This device falls under the Dental FDA review panel.
| 510(k) Number | K211813 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2021 |
| Decision Date | August 18, 2021 |
| Days to Decision | 68 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KJJ - Cleanser, Root Canal |
| Device Class | - |