K060335 is an FDA 510(k) clearance for the FILE-EZE. This device is classified as a Cleanser, Root Canal.
Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on February 24, 2006, 15 days after receiving the submission on February 9, 2006.
This device falls under the Dental FDA review panel.
| 510(k) Number | K060335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 2006 |
| Decision Date | February 24, 2006 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KJJ — Cleanser, Root Canal |
| Device Class | — |