The following data is part of a premarket notification filed by Ivoclar Vivadent Ag with the FDA for Tetric Evoflow Bulk Fill.
| Device ID | K150393 |
| 510k Number | K150393 |
| Device Name: | TETRIC EVOFLOW BULK FILL |
| Classification | Material, Tooth Shade, Resin |
| Applicant | IVOCLAR VIVADENT AG BENDERERSTRASSE 2 Schaan, LI Fl-9494 |
| Contact | Sandra Cakebread |
| Correspondent | Donna Marie Hartnett IVOCLAR VIVADENT, INC. 175 PINEVIEW DRIVE Amherst, NY 14228 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-18 |
| Decision Date | 2015-06-09 |
| Summary: | summary |