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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
Original Applicant
1 platin st, new industrial zone
rishon lezion,  IS 75653
Original Contact yuliya yukevich
Classification Product Code
Date Received04/20/2012
Decision Date 01/10/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No