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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K151150
Device Name Elements
Applicant
Pac-Dent International, Inc.
670 Endeavor Cir.
Brea,  CA  92821
Applicant Contact WENYING ZHU
Correspondent
Pac-Dent International, Inc.
670 Endeavor Cir.
Brea,  CA  92821
Correspondent Contact WENYING ZHU
Regulation Number872.3660
Classification Product Code
ELW  
Date Received04/30/2015
Decision Date 07/28/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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