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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Locator, Root Apex
510(k) Number K100450
Device Name I-ROOT
Applicant
S-Denti Co., Ltd.
505-14, Gasan-Dong
Geumcheon-Gu
Seongnam-City, Seoul,  KR 153-803
Applicant Contact TAE KYE NAM
Correspondent
S-Denti Co., Ltd.
505-14, Gasan-Dong
Geumcheon-Gu
Seongnam-City, Seoul,  KR 153-803
Correspondent Contact TAE KYE NAM
Classification Product Code
LQY  
Date Received02/17/2010
Decision Date 11/18/2010
Decision Substantially Equivalent (SESE)
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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