The following data is part of a premarket notification filed by Ivoclar Vivadent Ag with the FDA for Multilink Automix.
Device ID | K123397 |
510k Number | K123397 |
Device Name: | MULTILINK AUTOMIX |
Classification | Material, Tooth Shade, Resin |
Applicant | IVOCLAR VIVADENT AG BENDERERSTRASSE 2 Schaan, LI Fl-9494 |
Contact | Sandra Cakebread |
Correspondent | Sandra Cakebread IVOCLAR VIVADENT AG BENDERERSTRASSE 2 Schaan, LI Fl-9494 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-11-05 |
Decision Date | 2013-01-31 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() MULTILINK AUTOMIX 77053721 3282208 Live/Registered |
Ivoclar Vivadent, Inc. 2006-11-30 |