Estelite Omega

GUDID 04548190107414

PLT EA1

TOKUYAMA DENTAL CORPORATION

Dental composite resin
Primary Device ID04548190107414
NIH Device Record Key65b7481d-0889-45e5-a9e3-8c74c3ed26e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameEstelite Omega
Version Model Number10741
Company DUNS693552176
Company NameTOKUYAMA DENTAL CORPORATION
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Customer Support Contacts

Phone1-877-378-3548
Emailinfo@tokuyama-us.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104548190107414 [Primary]
GS194548190107417 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

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 Date2016-09-23

On-Brand Devices [Estelite Omega ]

04548190107513PLT BL2
04548190107506PLT BL1
04548190107490PLT DA3
04548190107483PLT DA2
04548190107476PLT DA1
04548190107469PLT MW
04548190107452PLT Trans
04548190107445PLT EB1
04548190107438PLT EA3
04548190107421PLT EA2
04548190107414PLT EA1
04548190107315Syringe BL2
04548190107308Syringe BL1
04548190107292Syringe DA3
04548190107285Syringe DA2
04548190107278Syringe DA1
04548190107261Syringe MW
04548190107254Syringe Trans
04548190107247Syringe EB1
04548190107230Syringe EA3
04548190107223Syringe EA2
04548190107216Syringe EA1
04548190107124PLT Basic Kit
04548190107117PLT Deluxe Kit
04548190107025Syringe Basic Kit
04548190107018Syringe Deluxe Kit

Trademark Results [Estelite Omega]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ESTELITE OMEGA
ESTELITE OMEGA
85129277 4104044 Live/Registered
Tokuyama Corporation
2010-09-14

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