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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 K242702
Device Name VioSeal
Applicant
Spident Co., Ltd.
203 & 312, Korea Industrial Complex, 722, Gojan-Dong,
Namdong-Gu
Incheon,  KR 405-821
Applicant Contact Eunok Choi
Correspondent
Spident Co., Ltd.
203 & 312, Korea Industrial Complex, 722, Gojan-Dong,
Namdong-Gu
Incheon,  KR 405-821
Correspondent Contact Eunok Choi
Regulation Number872.3820
Classification Product Code
KIF  
Date Received09/09/2024
Decision Date 11/07/2024
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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