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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 K911524
Device Name PALFIQUE ESTELITE
Applicant
Tokuyama America, Inc.
C/O Graham & James
2000 M St., NW, Suite 700
Washington,  DC  20036
Applicant Contact EMALEE G MURPHY
Correspondent
Tokuyama America, Inc.
C/O Graham & James
2000 M St., NW, Suite 700
Washington,  DC  20036
Correspondent Contact EMALEE G MURPHY
Regulation Number872.3690
Classification Product Code
EBF  
Date Received04/05/1991
Decision Date 05/29/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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