PALFIQUE LITEPOSTERIOR

Material, Tooth Shade, Resin

TOKUYAMA AMERICA, INC.

The following data is part of a premarket notification filed by Tokuyama America, Inc. with the FDA for Palfique Liteposterior.

Pre-market Notification Details

Device IDK913099
510k NumberK913099
Device Name:PALFIQUE LITEPOSTERIOR
ClassificationMaterial, Tooth Shade, Resin
Applicant TOKUYAMA AMERICA, INC. C/O GRAHAM & JAMES 2000 M STREET, N.W., SUITE 700 Washington,  DC  20036
ContactEmalee G Murphy
CorrespondentEmalee G Murphy
TOKUYAMA AMERICA, INC. C/O GRAHAM & JAMES 2000 M STREET, N.W., SUITE 700 Washington,  DC  20036
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-12
Decision Date1991-10-02

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