PALFIQUE ESTELITE

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 Estelite.

Pre-market Notification Details

Device IDK980054
510k NumberK980054
Device Name:PALFIQUE ESTELITE
ClassificationMaterial, Tooth Shade, Resin
Applicant TOKUYAMA AMERICA, INC. 1233 20TH., N.W. #700 Washington,  DC  20036
ContactDaniel J Manelli
CorrespondentDaniel J Manelli
TOKUYAMA AMERICA, INC. 1233 20TH., N.W. #700 Washington,  DC  20036
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-06
Decision Date1998-04-27
Summary:summary

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