K042846 is an FDA 510(k) clearance for the SYSTEMP.LINK. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on December 20, 2004, 66 days after receiving the submission on October 15, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K042846 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2004 |
| Decision Date | December 20, 2004 |
| Days to Decision | 66 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 |