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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 K182448
Device Name AnyRidge Octa 1 Implant System
Applicant
MegaGen Implant Co., Ltd.
45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun
daegu,  KR
Applicant Contact hyejin jung
Correspondent
LK Consulting Group USA, Inc.
690 Roosevelt
irvine,  CA  92620
Correspondent Contact priscilla chung
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received09/07/2018
Decision Date 10/09/2019
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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