K943475 is an FDA 510(k) clearance for the ULTRA HYDROPHILIC ALGINAE. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Essential Dental Systems, Inc. (South Hackensack, US). The FDA issued a Cleared decision on August 12, 1994, 24 days after receiving the submission on July 19, 1994.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K943475 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1994 |
| Decision Date | August 12, 1994 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | ELW - Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |