K902388 is an FDA 510(k) clearance for the DENTAL-QUECKSILBER (DENTAL MERCURY). This device is classified as a Mercury (Class II - Special Controls, product code ELY).
Submitted by Degussa AG (West Germany, DE). The FDA issued a Cleared decision on June 28, 1990, 29 days after receiving the submission on May 30, 1990.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3070.
| 510(k) Number | K902388 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 1990 |
| Decision Date | June 28, 1990 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | ELY — Mercury |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3070 |