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 |