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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
Bio Cetec Co., Ltd.
RM 1001-1002 New T Castle, 108, Gasan digital 2-ro
Seoul,  KR 08506
Applicant Contact Hee Sue Jin
MTech Group Inc.
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact Dave Kim
Regulation Number872.3640
Classification Product Code
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