The following data is part of a premarket notification filed by Ivoclar Vivadent, Ag with the FDA for Ips E.max Cad Abutment Solutions- Extra Systems.
| Device ID | K191382 |
| 510k Number | K191382 |
| Device Name: | IPS E.max CAD Abutment Solutions- Extra Systems |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Ivoclar Vivadent, AG Bendererstrasse 2 Schaan, LI Fl-9494 |
| Contact | Sandra Cakebread |
| Correspondent | Lori Aleshin Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, NY 14228 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-23 |
| Decision Date | 2019-08-26 |