BLUEPHASE
Activator, Ultraviolet, For Polymerization
IVOCLAR VIVADENT, INC.
The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Bluephase.
Pre-market Notification Details
| Device ID | K033520 |
| 510k Number | K033520 |
| Device Name: | BLUEPHASE |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Donna Marie Hartnett |
| Correspondent | Donna Marie Hartnett IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. 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 | 2003-11-07 |
| Decision Date | 2003-12-05 |
Trademark Results [BLUEPHASE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BLUEPHASE 76238483 2879886 Live/Registered |
IVOCLAR VIVADENT, INC. 2001-04-10 |
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