The following data is part of a premarket notification filed by Zirdent New Material Co., Ltd with the FDA for Zirdent Dental Zirconia Blank & Dental Zirconia Pre-shaded Blank.
| Device ID | K212259 |
| 510k Number | K212259 |
| Device Name: | Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank |
| Classification | Powder, Porcelain |
| Applicant | Zirdent New Material Co., Ltd No.101,3rd Building Of Hai Ping International Medical Device Industrial Area, No.229, Guyuan Road, Hi-tech New District Changsha, CN 410205 |
| Contact | Jia Li |
| Correspondent | Jinghua Zhou Guangzhou Junyi Information Technology Co., Ltd. Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town Huangpu District, Guangzhou City, CN 510663 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-20 |
| Decision Date | 2021-11-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16975018580114 | K212259 | 000 |
| 06975018580001 | K212259 | 000 |
| 06975018580018 | K212259 | 000 |
| 06975018580025 | K212259 | 000 |
| 06975018580049 | K212259 | 000 |
| 06975018580056 | K212259 | 000 |
| 06975018580063 | K212259 | 000 |
| 06975018580070 | K212259 | 000 |
| 06975018580087 | K212259 | 000 |
| 06975018580094 | K212259 | 000 |
| 16975018580107 | K212259 | 000 |
| 16975018580121 | K212259 | 000 |