The following data is part of a premarket notification filed by Kuraray Noritake Dental, Inc. with the FDA for Katana Zirconia.
| Device ID | K143439 |
| 510k Number | K143439 |
| Device Name: | KATANA Zirconia |
| Classification | Powder, Porcelain |
| Applicant | KURARAY NORITAKE DENTAL, INC. Ote Center Bldg. 7F, 1-1-3, Otemachi Chiyoda Ku, JP 1000004 |
| Contact | Michio Takigawa |
| Correspondent | Michio Takigawa KURARAY NORITAKE DENTAL, INC. Ote Center Bldg. 7F, 1-1-3, Otemachi Chiyoda Ku, JP 1000004 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-02 |
| Decision Date | 2015-02-27 |