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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 K212229
Device Name White Endoseal MTA
Applicant
Maruchi
2-208, Medical Industry Complex Bldg., 42-10,
Taejanggongdan-Gil
Wonju-Si,  KR 26311
Applicant Contact Jang Sung Wook
Correspondent
Maruchi
2-208, Medical Industry Complex Bldg., 42-10,
Taejanggongdan-Gil
Wonju-Si,  KR 26311
Correspondent Contact Jang Sung Wook
Regulation Number872.3820
Classification Product Code
KIF  
Date Received07/16/2021
Decision Date 08/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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