The following data is part of a premarket notification filed by Ivoclar Vivadent Ag with the FDA for Tetric Cad.
Device ID | K173573 |
510k Number | K173573 |
Device Name: | Tetric CAD |
Classification | Material, Tooth Shade, Resin |
Applicant | Ivoclar Vivadent AG Bendererstrasse 2 Schaan, LI 9494 |
Contact | Sandra Cakebread |
Correspondent | Donna 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 | 2017-11-20 |
Decision Date | 2018-06-07 |
Summary: | summary |