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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 K160577
Device Name PacEndo Chlorhexidine
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 Received03/01/2016
Decision Date 07/25/2016
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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