K010044 is an FDA 510(k) clearance for the COSMIC. This device is classified as a Alloy, Gold-based Noble Metal (Class II - Special Controls, product code EJT).
Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on February 9, 2001, 35 days after receiving the submission on January 5, 2001.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3060.
| 510(k) Number | K010044 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 2001 |
| Decision Date | February 09, 2001 |
| Days to Decision | 35 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 |