TETRIC EVOCERAM
Material, Tooth Shade, Resin
IVOCLAR VIVADENT, INC.
The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Tetric Evoceram.
Pre-market Notification Details
| Device ID | K042819 |
| 510k Number | K042819 |
| Device Name: | TETRIC EVOCERAM |
| Classification | Material, Tooth Shade, Resin |
| Applicant | IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Donna Hartnett |
| Correspondent | Donna Hartnett IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-12 |
| Decision Date | 2004-11-09 |
Trademark Results [TETRIC EVOCERAM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TETRIC EVOCERAM 77074118 3282272 Live/Registered |
Ivoclar Vivadent, Inc. 2007-01-02 |
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