K933178 is an FDA 510(k) clearance for the GDC 3509. This device is classified as a Alloy, Gold-based Noble Metal (Class II - Special Controls, product code EJT).
Submitted by Deringer-Ney, Inc. (Bloomfield, US). The FDA issued a Cleared decision on October 14, 1993, 106 days after receiving the submission on June 30, 1993.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3060.
| 510(k) Number | K933178 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 1993 |
| Decision Date | October 14, 1993 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EJT — Alloy, Gold-based Noble Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3060 |