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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 K897009
Device Name PALFIQUE LIGHT BONDING AGENT
Applicant
TOKUYAMA AMERICA, INC.
2000 M ST. NW
SUITE 700
WASHINGTON,  DC  20036
Applicant Contact EMALEE G MURPHY
Correspondent
TOKUYAMA AMERICA, INC.
2000 M ST. NW
SUITE 700
WASHINGTON,  DC  20036
Correspondent Contact EMALEE G MURPHY
Regulation Number872.3200
Classification Product Code
KLE  
Date Received12/13/1989
Decision Date 05/15/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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