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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K161774
Device Name i-Sil
Applicant
Spident Co., Ltd.
203 & 312, Korea Indsutrial Complex, 722
Gojan-Dong, Namdong-Gu
Incheon,  KR 21692
Applicant Contact J. M. Ahn
Correspondent
Spident USA, Inc.
2115 Linwood Ave., 5f,
Fort Lee,  NJ  07024
Correspondent Contact Mark Choi
Regulation Number872.3660
Classification Product Code
ELW  
Date Received06/28/2016
Decision Date 09/30/2016
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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