TEETHMATE™ F-1

GUDID EKUR001790KA1

Kit (Opaque)

KURARAY NORITAKE DENTAL INC.

Dental composite resin
Primary Device IDEKUR001790KA1
NIH Device Record Keyf1697b76-d24d-4f90-8040-0d463e80e6f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameTEETHMATE™ F-1
Version Model Number#1790-KA
Company DUNS697119498
Company NameKURARAY NORITAKE DENTAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEKUR001790KA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBCSealant, Pit And Fissure, And Conditioner

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-17

On-Brand Devices [TEETHMATE™ F-1]

EKUR001795KA1Opaque
EKUR001790KA1Kit (Opaque)
EKUR001765KA1Natural
EKUR001760KA1Kit (Natural)

Trademark Results [TEETHMATE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TEETHMATE
TEETHMATE
85484223 4236439 Live/Registered
Kuraray Co., Ltd.
2011-11-30
TEETHMATE
TEETHMATE
74598923 1970978 Live/Registered
KURARAY CO., LTD.
1994-11-15

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