The following data is part of a premarket notification filed by Ivoclar Vivadent Ag with the FDA for Ips E.max One.
| Device ID | K211916 |
| 510k Number | K211916 |
| Device Name: | IPS E.max One |
| Classification | Powder, Porcelain |
| Applicant | Ivoclar Vivadent AG Bendererstrasse 2 Schaan, LI Fl-9494 |
| Contact | Sandra Cakebread |
| Correspondent | Anderjeet Gulati Ivoclar Vivadent Inc 175 Pineview Drive Amherst, NY 14228 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-21 |
| Decision Date | 2021-08-20 |