The following data is part of a premarket notification filed by Baot Biological Technology Co., Ltd with the FDA for Dental Ceramic.
| Device ID | K182350 |
| 510k Number | K182350 |
| Device Name: | Dental Ceramic |
| Classification | Powder, Porcelain |
| Applicant | Baot Biological Technology Co., LTD Unit 1, Second Floor, No 12 Building, Yujing Industry Zone, 106 Qihao Road, Torch Development District Zhongshan, CN 528437 |
| Contact | Liqun Zhu |
| Correspondent | Liqun Zhu Baot Biological Technology Co., LTD Unit 1, Second Floor, No 12 Building, Yujing Industry Zone, 106 Qihao Road, Torch Development District Zhongshan, CN 528437 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-29 |
| Decision Date | 2019-05-22 |