The following data is part of a premarket notification filed by Ivoclar Vivadent, Ag with the FDA for Bluephase Powercure.
Device ID | K190272 |
510k Number | K190272 |
Device Name: | Bluephase PowerCure |
Classification | Activator, Ultraviolet, For Polymerization |
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 | EBZ |
CFR Regulation Number | 872.6070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-02-08 |
Decision Date | 2019-07-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() BLUEPHASE POWERCURE 79171560 4985929 Live/Registered |
IVOCLAR VIVADENT AG 2015-05-22 |