TOKUYAMA SOFRELINER TOUGH

Resin, Denture, Relining, Repairing, Rebasing

TOKUYAMA DENTAL CORPORATION

The following data is part of a premarket notification filed by Tokuyama Dental Corporation with the FDA for Tokuyama Sofreliner Tough.

Pre-market Notification Details

Device IDK030663
510k NumberK030663
Device Name:TOKUYAMA SOFRELINER TOUGH
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant TOKUYAMA DENTAL CORPORATION 2000 M ST. N.W. 7TH FLOOR Washington,  DC  20036 -3307
ContactDaniel J Manelli
CorrespondentDaniel J Manelli
TOKUYAMA DENTAL CORPORATION 2000 M ST. N.W. 7TH FLOOR Washington,  DC  20036 -3307
Product CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-03
Decision Date2003-05-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04548190233564 K030663 000
04548190233519 K030663 000

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