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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K192274
Device Name BV Dental Implant System
Applicant
Bio Concept Co., Ltd.
Unit C, #26, Huashan Middle Rd., Xinbei Zone
Changzhou,  CN 213022
Applicant Contact Xiaodong Dai
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received08/22/2019
Decision Date 06/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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