K003039 is an FDA 510(k) clearance for the GOLD CORE II. This device is classified as a Alloy, Metal, Base (Class II - Special Controls, product code EJH).
Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on December 5, 2000, 67 days after receiving the submission on September 29, 2000.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3710.
| 510(k) Number | K003039 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2000 |
| Decision Date | December 05, 2000 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EJH — Alloy, Metal, Base |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3710 |