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 |