The following data is part of a premarket notification filed by Changsha Honchon Technology Co., Ltd with the FDA for Dental Zirconia Blank & Dental Zirconia Pre-shaded Blank.
| Device ID | K221051 |
| 510k Number | K221051 |
| Device Name: | Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank |
| Classification | Powder, Porcelain |
| Applicant | Changsha Honchon Technology Co., LTD Room 627-628, Building 3th, Jinqiao Market Cluster Area 2, Purui Road No.1555, Wangcheng Changsha, CN 410200 |
| Contact | Ling Li |
| 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 | 2022-04-11 |
| Decision Date | 2022-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06977274260222 | K221051 | 000 |
| 06977274260109 | K221051 | 000 |
| 06977274260093 | K221051 | 000 |
| 06977274260086 | K221051 | 000 |
| 06977274260079 | K221051 | 000 |
| 06977274260062 | K221051 | 000 |
| 06977274260055 | K221051 | 000 |
| 06977274260048 | K221051 | 000 |
| 06977274260031 | K221051 | 000 |
| 06977274260024 | K221051 | 000 |
| 06977274260116 | K221051 | 000 |
| 06977274260123 | K221051 | 000 |
| 06977274260215 | K221051 | 000 |
| 06977274260208 | K221051 | 000 |
| 06977274260192 | K221051 | 000 |
| 06977274260185 | K221051 | 000 |
| 06977274260178 | K221051 | 000 |
| 06977274260161 | K221051 | 000 |
| 06977274260154 | K221051 | 000 |
| 06977274260147 | K221051 | 000 |
| 06977274260130 | K221051 | 000 |
| 06977274260017 | K221051 | 000 |