Oxford Zircore NANO A2

GUDID E12013A2

Premium Dual cure Core Build-up and Post Cementing Composite

First Scientific Dental Materials GmbH

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Primary Device IDE12013A2
NIH Device Record Key4741361d-9c47-46e8-8d2f-e8f73bdfcb25
Commercial Distribution StatusIn Commercial Distribution
Brand NameOxford Zircore NANO A2
Version Model Number12-013A2
Company DUNS341553292
Company NameFirst Scientific Dental Materials 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

Phone+494121909508
Emailinfo@oxford-scientific.de
Phone+494121909508
Emailinfo@oxford-scientific.de
Phone+494121909508
Emailinfo@oxford-scientific.de
Phone+494121909508
Emailinfo@oxford-scientific.de
Phone+494121909508
Emailinfo@oxford-scientific.de
Phone+494121909508
Emailinfo@oxford-scientific.de
Phone+494121909508
Emailinfo@oxford-scientific.de
Phone+494121909508
Emailinfo@oxford-scientific.de
Phone+494121909508
Emailinfo@oxford-scientific.de
Phone+494121909508
Emailinfo@oxford-scientific.de
Phone+494121909508
Emailinfo@oxford-scientific.de
Phone+494121909508
Emailinfo@oxford-scientific.de
Phone+494121909508
Emailinfo@oxford-scientific.de

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 20 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE12013A2 [Unit of Use]
HIBCCEFSM12013A20 [Primary]

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 Date2020-12-02
Device Publish Date2020-11-24

On-Brand Devices [Oxford Zircore NANO A2]

EFSM12001A20Premium Dual cure Core Build-up and Post Cementing Composite
E12013A2Premium Dual cure Core Build-up and Post Cementing Composite

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