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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K101621
Device Name LITE 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 Number872.3690
Classification Product Code
EBF  
Date Received06/09/2010
Decision Date 08/23/2010
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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