K926347 is an FDA 510(k) clearance for the DUCERANIUM U. This device is classified as a Alloy, Metal, Base (Class II - Special Controls, product code EJH).
Submitted by Degussa AG (South Plainfield, US). The FDA issued a Cleared decision on May 27, 1993, 161 days after receiving the submission on December 17, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3710.
| 510(k) Number | K926347 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 1992 |
| Decision Date | May 27, 1993 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EJH — Alloy, Metal, Base |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3710 |