The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Bluephase 20i.
| Device ID | K091020 |
| 510k Number | K091020 |
| Device Name: | BLUEPHASE 20I |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Donna Marie Hartnett |
| Correspondent | Donna Marie Hartnett IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-09 |
| Decision Date | 2009-06-12 |