Bluephase PowerCure
Activator, Ultraviolet, For Polymerization
Ivoclar Vivadent, AG
The following data is part of a premarket notification filed by Ivoclar Vivadent, Ag with the FDA for Bluephase Powercure.
Pre-market Notification Details
| 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 |
Trademark Results [Bluephase PowerCure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BLUEPHASE POWERCURE 79171560 4985929 Live/Registered |
IVOCLAR VIVADENT AG 2015-05-22 |
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