Estelite Universal 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 Estelite Universal Flow.

Pre-market Notification Details

Device IDK180613
510k NumberK180613
Device Name:Estelite Universal 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 Ave., S.W., Suite 1000 Washington,  DC  20024
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-08
Decision Date2018-07-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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04548190139996 K180613 000

Trademark Results [Estelite Universal Flow]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ESTELITE UNIVERSAL FLOW
ESTELITE UNIVERSAL FLOW
79190057 5178696 Live/Registered
TOKUYAMA CORPORATION
2016-05-12

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