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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Root Canal Filling
510(k) Number K170175
Device Name ENDOSEAL MTA
Applicant
Maruchi
2-208, 42-10 Taejanggongdan-Gil
Wonju-Si,  KR 26311
Applicant Contact Jang Sung Wook
Correspondent
LK Consulting Group USA, Inc.
800 Roosevelt
Suite 417
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number872.3820
Classification Product Code
KIF  
Date Received01/19/2017
Decision Date 02/26/2018
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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