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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 K080834
Device Name VINTAGE ART
Applicant
Shofu Dental Corp.
1225 Stone Dr.
San Marcos,  CA  92078
Applicant Contact DAVID P MORAIS
Correspondent
Shofu Dental Corp.
1225 Stone Dr.
San Marcos,  CA  92078
Correspondent Contact DAVID P MORAIS
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/25/2008
Decision Date 06/11/2008
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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