Omnichroma Flow

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.

Pre-market Notification Details

Device IDK193537
510k NumberK193537
Device Name:Omnichroma Flow
ClassificationMaterial, Tooth Shade, Resin
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. 1000 Maine Avenue, S.W. Suite 1000 Washington,  DC  20024
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-20
Decision Date2020-08-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04548190102204 K193537 000
04548190102204 K193537 000
04548190102204 K193537 000
04548190102204 K193537 000
04548190102204 K193537 000
04548190102204 K193537 000
04548190102204 K193537 000
04548190102204 K193537 000
04548190102204 K193537 000
04548190102204 K193537 000
04548190102204 K193537 000
04548190102204 K193537 000
04548190102204 K193537 000

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