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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 K071452
Device Name FL BOND II
Applicant
Shofu Dental Corp.
1225 Stone Dr.
San Marcos,  CA  92078
Applicant Contact DAVID MORAIS
Correspondent
Shofu Dental Corp.
1225 Stone Dr.
San Marcos,  CA  92078
Correspondent Contact DAVID MORAIS
Regulation Number872.3200
Classification Product Code
KLE  
Subsequent Product Code
EMA  
Date Received05/25/2007
Decision Date 07/09/2007
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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