K082470 is an FDA 510(k) clearance for the SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA. This device is classified as a Cleanser, Root Canal.
Submitted by Inter-Med, Inc. (Racine, US). The FDA issued a Cleared decision on April 3, 2009, 219 days after receiving the submission on August 27, 2008.
This device falls under the Dental FDA review panel.
| 510(k) Number | K082470 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 2008 |
| Decision Date | April 03, 2009 |
| Days to Decision | 219 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KJJ - Cleanser, Root Canal |
| Device Class | - |