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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.
Room# 511, 54, Changeop-ro, Sujeong-gu,
Seongnam-si,  KR 13449
Applicant Contact SungChul Moon
Correspondent
MK Meditech Inc.
Room# 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
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