K123538 is an FDA 510(k) clearance for the EPIEN ROOT CANAL CLEANSER. This device is classified as a Cleanser, Root Canal.
Submitted by Epien Medical, Inc. (Washington, US). The FDA issued a Cleared decision on February 1, 2013, 77 days after receiving the submission on November 16, 2012.
This device falls under the Dental FDA review panel.
| 510(k) Number | K123538 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2012 |
| Decision Date | February 01, 2013 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KJJ — Cleanser, Root Canal |
| Device Class | — |