The following data is part of a premarket notification filed by Ivoclar Vivadent Ag with the FDA for Ips Empress Direct Color Ips Empress Direct Opaque.
| Device ID | K121230 |
| 510k Number | K121230 |
| Device Name: | IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | IVOCLAR VIVADENT AG BENDERERSTRASSE 2 Schaan, LI Fl-9494 |
| Contact | Sandra Cakebread |
| Correspondent | Sandra Cakebread IVOCLAR VIVADENT AG BENDERERSTRASSE 2 Schaan, LI Fl-9494 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-24 |
| Decision Date | 2012-08-29 |