K063856 is an FDA 510(k) clearance for the EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM. This device is classified as a Resin, Root Canal Filling (Class II - Special Controls, product code KIF).
Submitted by Essential Dental Systems, Inc. (Great Neck, US). The FDA issued a Cleared decision on February 6, 2007, 40 days after receiving the submission on December 28, 2006.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3820.
| 510(k) Number | K063856 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2006 |
| Decision Date | February 06, 2007 |
| Days to Decision | 40 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KIF - Resin, Root Canal Filling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3820 |