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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 K170394
Device Name Kisses Mini
Applicant
Achimhai Medical Corporation
28, Namyang-Ro, 930beon-Gil, Namyang-Eup
Hwaseong-Si,  KR 18255
Applicant Contact Ji Ho Jung
Correspondent
LK Consulting Group USA, Inc.
800 Roosevelt
Suite 417
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received02/08/2017
Decision Date 10/06/2017
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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