Tokuyama Rebase III

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 Rebase Iii.

Pre-market Notification Details

Device IDK190940
510k NumberK190940
Device Name:Tokuyama Rebase III
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku Tokyo,  JP 110-0016
ContactKeith A. Barritt
CorrespondentKeith A. Barritt
Fish & Richardson P.C. 1001 Maine Ave., SW, Suite 1000 Washington,  DC  20024
Product CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-10
Decision Date2019-10-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04548190206636 K190940 000
04548190206629 K190940 000
04548190206612 K190940 000
04548190206605 K190940 000

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