TOKUYAMA SOFRELINER

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 Tokuyama Sofreliner.

Pre-market Notification Details

Device IDK982537
510k NumberK982537
Device Name:TOKUYAMA SOFRELINER
ClassificationResin, Denture, Relining, Repairing, Rebasing
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 CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-07-21
Decision Date1998-08-24
Summary:summary

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