CLEARFIL MAJESTY ES FLOW

Material, Tooth Shade, Resin

KURARAY NORITAKE DENTAL INC.

The following data is part of a premarket notification filed by Kuraray Noritake Dental Inc. with the FDA for Clearfil Majesty Es Flow.

Pre-market Notification Details

Device IDK130371
510k NumberK130371
Device Name:CLEARFIL MAJESTY ES FLOW
ClassificationMaterial, Tooth Shade, Resin
Applicant KURARAY NORITAKE DENTAL INC. OTE CENTER BLDG 7F 1-1-3, OTEMACHI Chiyoda-ku,  JP 100-0004
ContactMichio Takigawa
CorrespondentMichio Takigawa
KURARAY NORITAKE DENTAL INC. OTE CENTER BLDG 7F 1-1-3, OTEMACHI Chiyoda-ku,  JP 100-0004
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-02-14
Decision Date2013-04-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EKUR003331KA1 K130371 000
EKUR003302KA1 K130371 000
EKUR003303KA1 K130371 000
EKUR003304KA1 K130371 000
EKUR003305KA1 K130371 000
EKUR003306KA1 K130371 000
EKUR003307KA1 K130371 000
EKUR003308KA1 K130371 000
EKUR003309KA1 K130371 000
EKUR003312KA1 K130371 000
EKUR003317KA1 K130371 000
EKUR003301KA1 K130371 000

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