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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleanser, Root Canal
510(k) Number K153528
Device Name PacEndo EDTA
Applicant
Pac-Dent International, Inc.
670 Endeavor Circle
Brea,  CA  92821
Applicant Contact Wenying Zhu
Correspondent
Pac-Dent International, Inc.
670 Endeavor Circle
Brea,  CA  92821
Correspondent Contact Wenying Zhu
Classification Product Code
KJJ  
Date Received12/09/2015
Decision Date 02/01/2016
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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