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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cord, Retraction
510(k) Number K162662
Device Name GingiDent Gingival Retraction Paste
Applicant
Pac-Dent International, Inc.
670 Endeavor Cir.
Brea,  CA  92821
Applicant Contact JIAQING WU
Correspondent
Pac-Dent International, Inc.
670 Endeavor Cir.
Brea,  CA  92821
Correspondent Contact Jiahe Li
Classification Product Code
MVL  
Date Received09/26/2016
Decision Date 10/20/2017
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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