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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, Orthodontic
510(k) Number K190871
Device Name Bio-TackS Orthodontic Mini Implant
Applicant
Biocetec Co., Ltd.
Rm.1001-1002 New T Castle, 108, Gasan Digital 2-Ro
Geumcheon-Gu
Seoul,  KR 08506
Applicant Contact Hee Sue Jin
Correspondent
Mtech Group, Inc.
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact Dave Kim
Regulation Number872.3640
Classification Product Code
OAT  
Date Received04/03/2019
Decision Date 01/17/2020
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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