K071106 is an FDA 510(k) clearance for the ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399. 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 May 8, 2007, 19 days after receiving the submission on April 19, 2007.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3820.
| 510(k) Number | K071106 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2007 |
| Decision Date | May 08, 2007 |
| Days to Decision | 19 days |
| Submission Type | Special |
| 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 |