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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K203808
Device Name Multi-unit Abutment, Multi-unit Angled Abutment
Applicant
MegaGen Implant Co. Ltd.
45, Secheon-ro, 7-gil
Daegu,  KR 42921
Applicant Contact You Jung Kim
Correspondent
DaeGyeong Regulatory Affairs Institute
32, Innovalley-ro
Daegu,  KR 41065
Correspondent Contact You Jung Kim
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/28/2020
Decision Date 10/20/2021
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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