K121230 is an FDA 510(k) clearance for the IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on August 29, 2012, 127 days after receiving the submission on April 24, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K121230 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2012 |
| Decision Date | August 29, 2012 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBF — Material, Tooth Shade, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3690 |