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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K190079
Device Name ArgenZ HT+
Applicant
The Argen Corporation
5855 Oberlin Dr.
San Diego,  CA  92121
Applicant Contact Craig Jolicoeur
Correspondent
The Argen Corporation
5855 Oberlin Dr.
San Diego,  CA  92121
Correspondent Contact Craig Jolicoeur
Regulation Number872.6660
Classification Product Code
EIH  
Date Received01/16/2019
Decision Date 04/12/2019
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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