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 |