BISTITE II SC

Cement, Dental

TOKUYAMA AMERICA, INC.

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

Pre-market Notification Details

Device IDK991711
510k NumberK991711
Device Name:BISTITE II SC
ClassificationCement, Dental
Applicant TOKUYAMA AMERICA, INC. 2000 M ST. NW SUITE 700 Washington,  DC  20036
ContactDaniel J Manelli
CorrespondentDaniel J Manelli
TOKUYAMA AMERICA, INC. 2000 M ST. NW SUITE 700 Washington,  DC  20036
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-19
Decision Date1999-07-07
Summary:summary

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