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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K240754
Device Name N2
Applicant
Megagen Implant Co., Ltd.
45, Secheon-Ro
Daegu,  KR 42921
Applicant Contact Lee Hyo-Eun
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number872.6640
Classification Product Code
EIA  
Date Received03/20/2024
Decision Date 03/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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