The following data is part of a premarket notification filed by Kerr Corporation with the FDA for Simplishade Bulk Fill, Simplishade Bulk Fill Flow.
| Device ID | K221255 |
| 510k Number | K221255 |
| Device Name: | SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Kerr Corporation 1889 W Mission Blvd Pomona, CA 91766 |
| Contact | Haiyan Wei |
| Correspondent | Haiyan Wei Kerr Corporation 1889 W Mission Blvd Pomona, CA 91766 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-02 |
| Decision Date | 2022-08-31 |