BV Dental Implant System

Implant, Endosseous, Root-form

Bio Concept Co., Ltd

The following data is part of a premarket notification filed by Bio Concept Co., Ltd with the FDA for Bv Dental Implant System.

Pre-market Notification Details

Device IDK192274
510k NumberK192274
Device Name:BV Dental Implant System
ClassificationImplant, Endosseous, Root-form
Applicant Bio Concept Co., Ltd Unit C, No.26, Huashan Middle Road, Xinbei Zone Changzhou,  CN 213022
ContactXiaodong Dai
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai,  CN 200120
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-22
Decision Date2020-06-18

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