The following data is part of a premarket notification filed by Kuraray Noritake Dental Inc. with the FDA for Katana Zirconia.
| Device ID | K131534 |
| 510k Number | K131534 |
| Device Name: | KATANA ZIRCONIA |
| Classification | Powder, Porcelain |
| Applicant | KURARAY NORITAKE DENTAL INC. 700 12TH ST SW SUITE 100 Washington, DC 20005 |
| Contact | Ivan Wasserman |
| Correspondent | Ivan Wasserman KURARAY NORITAKE DENTAL INC. 700 12TH ST SW SUITE 100 Washington, DC 20005 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-29 |
| Decision Date | 2013-10-11 |