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 |