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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 K112153
Device Name IROOT 100 MINI
Applicant
S-Denti Co., Ltd.
300, Atwood
Pittsburgh,  PA  15213
Applicant Contact PETER CHUNG
Correspondent
S-Denti Co., Ltd.
300, Atwood
Pittsburgh,  PA  15213
Correspondent Contact PETER CHUNG
Classification Product Code
LQY  
Date Received07/07/2011
Decision Date 04/26/2012
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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