The following data is part of a premarket notification filed by Hunan Vsmile Biotechnology Co., Ltd with the FDA for Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-shaded Blank.
| Device ID | K221242 |
| 510k Number | K221242 |
| Device Name: | Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank |
| Classification | Powder, Porcelain |
| Applicant | Hunan Vsmile Biotechnology Co., Ltd Juxing 501-5,501-6, Lujing Road No.8, Lugu High-tech Zone Changsha, CN 410000 |
| Contact | Xiaomi Tang |
| Correspondent | Shanfeng Jiang 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 | 2022-05-02 |
| Decision Date | 2022-07-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974668761556 | K221242 | 000 |
| 06974668761457 | K221242 | 000 |
| 06974668761464 | K221242 | 000 |
| 06974668761471 | K221242 | 000 |
| 06974668761488 | K221242 | 000 |
| 06974668761495 | K221242 | 000 |
| 06974668761501 | K221242 | 000 |
| 06974668761518 | K221242 | 000 |
| 06974668761525 | K221242 | 000 |
| 06974668761532 | K221242 | 000 |
| 06974668761549 | K221242 | 000 |
| 06974668761440 | K221242 | 000 |