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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 K121206
Device Name DETECT
Applicant
Forum Engineering Technologies, Ltd.
1 Platin St., New Industrial Zone
Rishon Lezion,  IL 75653
Applicant Contact YULIYA YUKEVICH
Correspondent
Forum Engineering Technologies, Ltd.
1 Platin St., New Industrial Zone
Rishon Lezion,  IL 75653
Correspondent Contact YULIYA YUKEVICH
Classification Product Code
LQY  
Date Received04/20/2012
Decision Date 01/10/2013
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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