The following data is part of a premarket notification filed by Ivoclar Vivadent Ag with the FDA for Ips E.max® Press Abutment Solutions For Viteo Base Ti.
| Device ID | K160798 |
| 510k Number | K160798 |
| Device Name: | IPS E.max® Press Abutment Solutions For Viteo Base Ti |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | IVOCLAR VIVADENT AG BENDERERSTRASSE 2 Schaan, LI Fl-9494 |
| Contact | Sandra Cakebread |
| Correspondent | Donna Marie Hartnett 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 | 2016-03-23 |
| Decision Date | 2016-12-15 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IPS E.MAX 79005918 3076872 Dead/Cancelled |
Ivoclar Vivadent AG 2004-08-30 |
![]() IPS E.MAX 78891215 3251293 Live/Registered |
Ivoclar Vivadent, Inc. 2006-05-24 |