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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 K262050
Device Name Vioseal X
Applicant
Spident Co., Ltd.
203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdon
Incheon,  KR 405-821
Applicant Contact Eunok Choi
Correspondent
Spident Co., Ltd.
203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdon
Incheon,  KR 405-821
Correspondent Contact Eunok Choi
Regulation Number872.3820
Classification Product Code
KIF  
Date Received06/18/2026
Decision Date 09/11/2026
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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