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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 K112508
Device Name I-ROOT 100
Applicant
S-DENTI CO., LTD.
VALLEY 6,481-4
GASAN-DONG GEUMCHEON-GU
TAE KYE NAM,  KR 153-803
Applicant Contact TAE K NAM
Correspondent
S-DENTI CO., LTD.
VALLEY 6,481-4
GASAN-DONG GEUMCHEON-GU
TAE KYE NAM,  KR 153-803
Correspondent Contact TAE K NAM
Classification Product Code
LQY  
Date Received08/30/2011
Decision Date 06/19/2012
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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