GrandioSO Light Flow 2587

GUDID E2212587

highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour A2

VOCO GmbH

Dental composite resin
Primary Device IDE2212587
NIH Device Record Key8bc4c5b8-0476-4804-b6af-ae6d6920ef57
Commercial Distribution StatusIn Commercial Distribution
Brand NameGrandioSO Light Flow
Version Model Number2587
Catalog Number2587
Company DUNS316699578
Company NameVOCO GmbH
Device Count2
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

Customer Support Contacts

Phone999-999-9999
Emailxxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE2212587 [Unit of Use]
HIBCCE22125871 [Primary]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-08
Device Publish Date2020-03-31

On-Brand Devices [GrandioSO Light Flow]

E2212593highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour Incisal (I)
E2212592highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour OA2
E2212591highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour WO
E2212590highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour B1
E2212589highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour A3.5
E2212588highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour A3
E2212587highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour A2
E2212586highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour A1
E2212585highly flowable, light-curing, radiopaque nano-hybrid restorative material The set contains 5 di

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