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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 K262478
Device Name BCS Bioceramic Sealer
Applicant
BCS Device Pte., Ltd.
16 Kallang Pl. #03-31
Singapore,  SG 339156
Applicant Contact Yongze Lyu
Correspondent
BCS Device Pte., Ltd.
16 Kallang Pl. #03-31
Singapore,  SG 339156
Correspondent Contact Yongze Lyu
Regulation Number872.3820
Classification Product Code
KIF  
Date Received07/20/2026
Decision Date 10/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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