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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 K210559
Device Name ATOZ Mini-Screw
Applicant
Mk Meditech, Inc.
Rm.# 511, 54, Changeop-Ro, Sujeong-Gu,
Seongnam-Si,  KR 13449
Applicant Contact SungChul Moon
Correspondent
Mk Meditech, Inc.
Rm.# 511, 54, Changeop-Ro, Sujeong-Gu,
Seongnam-Si,  KR 13449
Correspondent Contact SungChul Moon
Regulation Number872.3640
Classification Product Code
OAT  
Date Received02/25/2021
Decision Date 12/19/2021
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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