White ENDOSEAL MTA

Resin, Root Canal Filling

Maruchi

The following data is part of a premarket notification filed by Maruchi with the FDA for White Endoseal Mta.

Pre-market Notification Details

Device IDK202015
510k NumberK202015
Device Name:White ENDOSEAL MTA
ClassificationResin, Root Canal Filling
Applicant Maruchi 2-208, Medical Industry Complex Bldg., 42-10, Taejanggongdan-gil Wonju-si,  KR 26311
ContactSung Wook Jang
CorrespondentSung Wook Jang
Maruchi 2-208, Medical Industry Complex Bldg., 42-10, Taejanggongdan-gil Wonju-si,  KR 26311
Product CodeKIF  
CFR Regulation Number872.3820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-21
Decision Date2021-03-24

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