The following data is part of a premarket notification filed by Aidite (qinhuangdao) Technology Co., Ltd. with the FDA for Dental Zirconia Ceramic.
| Device ID | K213570 |
| 510k Number | K213570 |
| Device Name: | Dental Zirconia Ceramic |
| Classification | Powder, Porcelain |
| Applicant | Aidite (Qinhuangdao) Technology Co., Ltd. No.9 Dushan Road,Economic And Technological Development Zone, Qinhuangdao, CN 066004 |
| Contact | Wang Lili |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lu Jiazui Rd.,Pudong Shanghai, CN 200120 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-10 |
| Decision Date | 2022-01-07 |