K033446 is an FDA 510(k) clearance for the APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82. This device is classified as a Alloy, Gold-based Noble Metal (Class II - Special Controls, product code EJT).
Submitted by We Dong Myung Dental Industrial Co., Ltd. (Marietta, US). The FDA issued a Cleared decision on November 13, 2003, 15 days after receiving the submission on October 29, 2003.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3060.
| 510(k) Number | K033446 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 2003 |
| Decision Date | November 13, 2003 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EJT — Alloy, Gold-based Noble Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3060 |