LuxaBond - Total Etch 212384

GUDID EDMG2123841

Total Etch dual cure adhesive system. The perfect partner for all direct and indirect techniques. Content: 1 bottle @ 5 ml Pre-Bond, 1 bottle @ 5 ml Bond A, 1 bottle @ 5 ml Bond B, 1 syringe @ 2 ml DMG Etching Gel Medium Viscosity, Accessories.

DMG Chemisch-Pharmazeutische Fabrik GmbH

Dental etching solution
Primary Device IDEDMG2123841
NIH Device Record Key6a1c1075-56dc-497c-904a-20bb8f0c1ae5
Commercial Distribution StatusIn Commercial Distribution
Brand NameLuxaBond - Total Etch
Version Model Number212384
Catalog Number212384
Company DUNS320744915
Company NameDMG Chemisch-Pharmazeutische Fabrik GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
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

Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Close bottle immediately after use!
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Close bottle immediately after use!
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Close bottle immediately after use!
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Close bottle immediately after use!
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Close bottle immediately after use!
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Close bottle immediately after use!
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Close bottle immediately after use!
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Close bottle immediately after use!
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Close bottle immediately after use!
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Close bottle immediately after use!
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Close bottle immediately after use!
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Close bottle immediately after use!
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Close bottle immediately after use!
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEDMG2123841 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAgent, Tooth Bonding, 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

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