Grandio SO 2635

GUDID E22126351

Universal nano-hybrid restorative material

VOCO GmbH

Dental composite resin
Primary Device IDE22126351
NIH Device Record Key2fca80b2-dd12-4a1a-bb93-5ad60e811b90
Commercial Distribution StatusIn Commercial Distribution
Brand NameGrandio SO
Version Model Number2635
Catalog Number2635
Company DUNS316699578
Company NameVOCO GmbH
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

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
HIBCCE22126351 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-31

On-Brand Devices [Grandio SO]

E22126481Universal nano-hybrid restorative material
E22126751Universal nano-hybrid restorative material
E22126731Universal nano-hybrid restorative material
E22126711Universal nano-hybrid restorative material
E22126701Universal nano-hybrid restorative material
E22126691Universal nano-hybrid restorative material
E22126671Universal nano-hybrid restorative material
E22126641Universal nano-hybrid restorative material
E22126611Universal nano-hybrid restorative material
E22126601Universal nano-hybrid restorative material
E22126591Universal nano-hybrid restorative material
E22126561Universal nano-hybrid restorative material
E22126551Universal nano-hybrid restorative material
E22126541Universal nano-hybrid restorative material
E22126531Universal nano-hybrid restorative material
E22126521Universal nano-hybrid restorative material
E22126511Universal nano-hybrid restorative material
E22126501Universal nano-hybrid restorative material
E22126461Universal nano-hybrid restorative material Trial pack.
E22126401Universal nano-hybrid restorative material. The kit contains different shades of Grandio SO and
E22126351Universal nano-hybrid restorative material
E22126331Universal nano-hybrid restorative material
E22126311Universal nano-hybrid restorative material
E22126301Universal nano-hybrid restorative material
E22126291Universal nano-hybrid restorative material
E22126271Universal nano-hybrid restorative material
E22126241Universal nano-hybrid restorative material
E22126211Universal nano-hybrid restorative material
E22126201Universal nano-hybrid restorative material
E22126191Universal nano-hybrid restorative material
E22126161Universal nano-hybrid restorative material
E22126151Universal nano-hybrid restorative material
E22126141Universal nano-hybrid restorative material
E22126131Universal nano-hybrid restorative material
E22126121Universal nano-hybrid restorative material
E22126111Universal nano-hybrid restorative material
E22126101Universal nano-hybrid restorative material
E22126011Universal nano-hybrid restorative material. The kit contains different shades of Grandio SO and
E22126001Universal nano-hybrid restorative material. The kit contains different shades of Grandio SO and
E22126071Grandio SO shade guide.

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