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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 K170031
Device Name Internal Octa Implant System
Applicant
Ebi, Inc.
124, Uisong-Gil, Amnyang-Myeon
Gyeongsan-Si,  KR 38493
Applicant Contact Mi Sook Kim
Correspondent
Withus Group, Inc.
2531 Pepperdale Dr.
Rowland Heights,  CA  91748
Correspondent Contact April Lee
Regulation Number872.3640
Classification Product Code
DZE  
Date Received01/04/2017
Decision Date 08/31/2017
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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