The following data is part of a premarket notification filed by Noritake Co., Inc. with the FDA for Cerabien Zr.
| Device ID | K031968 |
| 510k Number | K031968 |
| Device Name: | CERABIEN ZR |
| Classification | Powder, Porcelain |
| Applicant | NORITAKE CO., INC. 3050 K STREET, NW, STE 400 Washington, DC 20007 |
| Contact | Ivan J Wasserman |
| Correspondent | Ivan J Wasserman NORITAKE CO., INC. 3050 K STREET, NW, STE 400 Washington, DC 20007 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-26 |
| Decision Date | 2003-12-22 |