K941625 is an FDA 510(k) clearance for the DW234 #29. This device is classified as a Alloy, Other Noble Metal (Class II - Special Controls, product code EJS).
Submitted by Rms Div. (Amherst, US). The FDA issued a Cleared decision on June 22, 1994, 79 days after receiving the submission on April 4, 1994.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3060.
| 510(k) Number | K941625 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 1994 |
| Decision Date | June 22, 1994 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EJS — Alloy, Other Noble Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3060 |