The following data is part of a premarket notification filed by Ivoclar Vivadent, Ag with the FDA for Bluephase Style 20i.
Device ID | K163613 |
510k Number | K163613 |
Device Name: | Bluephase Style 20i |
Classification | Activator, Ultraviolet, For Polymerization |
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 | EBZ |
CFR Regulation Number | 872.6070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-12-22 |
Decision Date | 2017-04-04 |
Summary: | summary |