The following data is part of a premarket notification filed by Kuraray Noritake Dental Inc. with the FDA for Cerabien Zr.
| Device ID | K170834 |
| 510k Number | K170834 |
| Device Name: | CERABIEN ZR |
| Classification | Powder, Porcelain |
| Applicant | Kuraray Noritake Dental Inc. Ote Center Bldg. 7F Chiyoda-ku, JP 100-0004 |
| Contact | Yasujiro Ohara |
| Correspondent | Yasujiro Ohara Kuraray Noritake Dental Inc. Ote Center Bldg. 7F Chiyoda-ku, JP 100-0004 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-20 |
| Decision Date | 2017-10-17 |