The following data is part of a premarket notification filed by Shenzhen Yurucheng Dental Materials Co., Ltd. with the FDA for Zirconia Dental Ceramics.
| Device ID | K214005 |
| 510k Number | K214005 |
| Device Name: | Zirconia Dental Ceramics |
| Classification | Powder, Porcelain |
| Applicant | Shenzhen Yurucheng Dental Materials Co., Ltd. 101-201, Building 4, No.1 Branch Of Zhongcheng Life Science Park, No. 14 Zhongxing Road Shenzhen, CN 518000 |
| Contact | Fiya Liao |
| Correspondent | Grace Liu Shenzhen Joyantech Consulting Co. Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, CN 518000 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-21 |
| Decision Date | 2022-02-18 |