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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 K171179
Device Name BR Type Implant System
Applicant
Biotem Co., Ltd.
57, Sasang-Ro, 401 Beon-Gil, Sasang-Gu
Busan,  KR
Applicant Contact Hong Koo Yeo
Correspondent
Provision Consulting Group, Inc.
1370 Valley Vista Dr.
Suite 200
Diamond Bar,  CA  91765
Correspondent Contact Joyce Bang
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received04/24/2017
Decision Date 02/09/2018
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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