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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 K222142
Device Name BR SLA Type Implant System
Applicant
Biotem Co., Ltd.
57, Sasang-Ro, 401 Beon-Gil, Sasang-Gu
Busan,  KR 46925
Applicant Contact Hong Koo Yeo
Correspondent
Provision Consulting Group, Inc.
100 N Barranca St., Suite 700
West Covina,  CA  91791
Correspondent Contact Joyce Kwon
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received07/20/2022
Decision Date 06/24/2023
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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