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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 K252285
Device Name Well-Root PT
Applicant
Vericom Co., Ltd.
48,Toegyegongdan 1-Gil
Chuncheon-Si,  KR 24427
Applicant Contact Yunki Kim
Correspondent
Vericom Co., Ltd.
48,Toegyegongdan 1-Gil
Chuncheon-Si,  KR 24427
Correspondent Contact Yunki Kim
Regulation Number872.3820
Classification Product Code
KIF  
Date Received07/23/2025
Decision Date 09/19/2025
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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