The following data is part of a premarket notification filed by Ivoclar Vivadent, Ag with the FDA for Tetric Powerfill.
Device ID | K183380 |
510k Number | K183380 |
Device Name: | Tetric PowerFill |
Classification | Material, Tooth Shade, Resin |
Applicant | Ivoclar Vivadent, AG Bendererstrasse 2 Schaan, LI Fl-9494 |
Contact | Schaan Cakebread |
Correspondent | Lori Aleshin 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 | 2018-12-06 |
Decision Date | 2019-03-14 |
Summary: | summary |