TOKUSO REBASE

Resin, Denture, Relining, Repairing, Rebasing

TOKUYAMA AMERICA, INC.

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

Pre-market Notification Details

Device IDK896981
510k NumberK896981
Device Name:TOKUSO REBASE
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant TOKUYAMA AMERICA, INC. 2000 M ST. NW SUITE 700 Washington,  DC  20036
ContactEmalee G Murphy
CorrespondentEmalee G Murphy
TOKUYAMA AMERICA, INC. 2000 M ST. NW SUITE 700 Washington,  DC  20036
Product CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-13
Decision Date1990-05-15

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