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 |