K933543 is an FDA 510(k) clearance for the ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT). This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Jedental Co., Inc. (Southampton, US). The FDA issued a Cleared decision on November 1, 1993, 104 days after receiving the submission on July 20, 1993.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K933543 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 1993 |
| Decision Date | November 01, 1993 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EMA — Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |