Estelite Flow Quick High Flow

GUDID 04548190120826

PLT A2

TOKUYAMA DENTAL CORPORATION

Dental composite resin
Primary Device ID04548190120826
NIH Device Record Keya71db7d7-5b62-4c77-b7ca-74ef36fa68fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameEstelite Flow Quick High Flow
Version Model Number12082
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
GS104548190120826 [Primary]
GS194548190120829 [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 Flow Quick High Flow ]

04548190123919Syringe A2 Mini
04548190121748Syringe OPA2
04548190121731Syringe A3
04548190121724Syringe A2
04548190121717Syringe A1
04548190120840PLT OPA2
04548190120833PLT A3
04548190120826PLT A2
04548190120819PLT A1

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