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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K110235
Device Name BEAUTIBOND MULTI
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 Number872.3200
Classification Product Code
KLE  
Date Received01/26/2011
Decision Date 05/13/2011
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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