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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, Root-Form
510(k) Number K210161
Device Name AnyOne Onestage Implant System
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 Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received01/21/2021
Decision Date 06/22/2021
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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