K140846 is an FDA 510(k) clearance for the EDS COMBO-RINSE. This device is classified as a Cleanser, Root Canal.
Submitted by Essential Dental Systems, Inc. (South Hackensack, US). The FDA issued a Cleared decision on July 25, 2014, 113 days after receiving the submission on April 3, 2014.
This device falls under the Dental FDA review panel.
| 510(k) Number | K140846 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2014 |
| Decision Date | July 25, 2014 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KJJ - Cleanser, Root Canal |
| Device Class | - |