Oxford Bond TE Mono

GUDID EFSM200010

Total Etch Adhesive - Light Cure

First Scientific Dental Materials GmbH

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Primary Device IDEFSM200010
NIH Device Record Key962ad257-80b3-4c8e-8879-048319f86803
Commercial Distribution StatusIn Commercial Distribution
Brand NameOxford Bond TE Mono
Version Model Number20-001
Company DUNS341553292
Company NameFirst Scientific Dental Materials 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

Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de
Phone+4904121909508
Emailinfo@oxford-scientific.de

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEFSM200010 [Primary]

FDA Product Code

KLEAgent, Tooth Bonding, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-14
Device Publish Date2020-09-06

Devices Manufactured by First Scientific Dental Materials GmbH

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EFSM12001BLUE0 - Oxford Zircore NANO Blue2020-12-02 Premium Dual cure Core Build-up and Post Cementing Composite
EFSM12005A30 - Oxford Flo CEM A32020-12-02 Dual Cure Flowable Composite Cement
E12013A2 - Oxford Zircore NANO A22020-12-02 Premium Dual cure Core Build-up and Post Cementing Composite
E15002 - Oxford Root FILL System2020-12-02 Dual Cure Permanent Root Canal Sealing and Filling Material
EFSM210050 - Oxford Universal Bond2020-12-02 Universal Adhesive
EFSM30001A30 - Oxford Temp A32020-12-02 Temporary Crown & Bridge Material 10:1

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