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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 K071410
Device Name ARGEN PEARL BRAND ZIRCONIA
Applicant
The Argen Corporation
5855 Oberlin Dr.
San Diego,  CA  92121
Applicant Contact PAUL CASCONE
Correspondent
The Argen Corporation
5855 Oberlin Dr.
San Diego,  CA  92121
Correspondent Contact PAUL CASCONE
Regulation Number872.6660
Classification Product Code
EIH  
Date Received05/21/2007
Decision Date 08/15/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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