FDA 510(k) Application Details - K131907

Device Classification Name Locator, Root Apex

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510(K) Number K131907
Device Name Locator, Root Apex
Applicant DENTSPLY INTERNATIONAL INC.
221 WEST PHILADELPHIA ST.
SUITE 60
YORK, PA 17401 US
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Contact HELEN LEWIS
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Regulation Number 000.0000

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Classification Product Code LQY
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Date Received 06/26/2013
Decision Date 01/31/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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