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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 K231480
Device Name Bright MTA Sealer Plus
Applicant
Genoss Co., Ltd.
D-Factory, 56, Changnyong-Daero 256beon-Gil, Yeongtong-Gu
Suwon-Si,  KR 16229
Applicant Contact Boram Choi
Correspondent
Genoss Co., Ltd.
D-Factory, 56, Changnyong-Daero 256beon-Gil, Yeongtong-Gu
Suwon-Si,  KR 16229
Correspondent Contact Boram Choi
Regulation Number872.3820
Classification Product Code
KIF  
Date Received05/22/2023
Decision Date 07/28/2023
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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