K042756 is an FDA 510(k) clearance for the ENDOREZ. This device is classified as a Resin, Root Canal Filling (Class II - Special Controls, product code KIF).
Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on October 26, 2004, 22 days after receiving the submission on October 4, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3820.
| 510(k) Number | K042756 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 2004 |
| Decision Date | October 26, 2004 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | KIF — Resin, Root Canal Filling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3820 |