Omnichroma Flow Bulk

Material, Tooth Shade, Resin

Tokuyama Dental Corporation

The following data is part of a premarket notification filed by Tokuyama Dental Corporation with the FDA for Omnichroma Flow Bulk.

Pre-market Notification Details

Device IDK203598
510k NumberK203598
Device Name:Omnichroma Flow Bulk
ClassificationMaterial, Tooth Shade, Resin
Applicant Tokuyama Dental Corporation 38-9 Taitou 1-chome Taitou-ku,  JP 110-0016
ContactKeith A. Baritt
CorrespondentKeith A. Baritt
Fish & Richardson P.C. 1000 Maine Avenue, S.W. Suite 1000 Wasington,  DC  20024
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-09
Decision Date2021-02-03

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