The following data is part of a premarket notification filed by Bio Concept Co., Ltd with the FDA for Bv Dental Implant System.
Device ID | K192274 |
510k Number | K192274 |
Device Name: | BV Dental Implant System |
Classification | Implant, Endosseous, Root-form |
Applicant | Bio Concept Co., Ltd Unit C, No.26, Huashan Middle Road, Xinbei Zone Changzhou, CN 213022 |
Contact | Xiaodong Dai |
Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-08-22 |
Decision Date | 2020-06-18 |