The following data is part of a premarket notification filed by Kuraray Noritake Dental, Inc. with the FDA for Katana Avencia Block.
| Device ID | K153476 |
| 510k Number | K153476 |
| Device Name: | KATANA AVENCIA Block |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Kuraray Noritake Dental, Inc. Ote Center Bldg. 7F, 1-1-3, Otemachi Chiyoda Ku, JP 100-0004 |
| Contact | Michio Takigawa |
| Correspondent | Michio Takigawa Kuraray Noritake Dental, Inc. Ote Center Bldg. 7F, 1-1-3, Otemachi Chiyoda Ku, JP 100-0004 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-02 |
| Decision Date | 2016-08-23 |