K051010 is an FDA 510(k) clearance for the SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70. This device is classified as a Alloy, Amalgam (Class II - Special Controls, product code EJJ).
Submitted by Septodont (Washington, US). The FDA issued a Cleared decision on May 2, 2005, 11 days after receiving the submission on April 21, 2005.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3070.
| 510(k) Number | K051010 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 2005 |
| Decision Date | May 02, 2005 |
| Days to Decision | 11 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EJJ - Alloy, Amalgam |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3070 |