MatrixTemp Temporary Crown and Bridge Material

GUDID 10859787002021

Self-cure resin based impression material for the fabrication of temporary crowns and bridges

ADVANTAGE DENTAL PRODUCTS INC

Dental crown/bridge resin, temporary Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin
Primary Device ID10859787002021
NIH Device Record Key1e844dec-6d28-47a1-8350-e5ec22605a31
Commercial Distribution StatusIn Commercial Distribution
Brand NameMatrixTemp Temporary Crown and Bridge Material
Version Model Number102
Company DUNS607859147
Company NameADVANTAGE DENTAL PRODUCTS INC
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone248-391-1625
Emailcontact@advantagedentalinc.com
Phone248-391-1625
Emailcontact@advantagedentalinc.com
Phone248-391-1625
Emailcontact@advantagedentalinc.com
Phone248-391-1625
Emailcontact@advantagedentalinc.com
Phone248-391-1625
Emailcontact@advantagedentalinc.com
Phone248-391-1625
Emailcontact@advantagedentalinc.com
Phone248-391-1625
Emailcontact@advantagedentalinc.com
Phone248-391-1625
Emailcontact@advantagedentalinc.com
Phone248-391-1625
Emailcontact@advantagedentalinc.com
Phone248-391-1625
Emailcontact@advantagedentalinc.com
Phone248-391-1625
Emailcontact@advantagedentalinc.com
Phone248-391-1625
Emailcontact@advantagedentalinc.com
Phone248-391-1625
Emailcontact@advantagedentalinc.com
Phone248-391-1625
Emailcontact@advantagedentalinc.com
Phone248-391-1625
Emailcontact@advantagedentalinc.com
Phone248-391-1625
Emailcontact@advantagedentalinc.com
Phone248-391-1625
Emailcontact@advantagedentalinc.com

Device Dimensions

Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter
Total Volume50 Milliliter

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Use with adequate ventilation and store away from oxidizing materials
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Use with adequate ventilation and store away from oxidizing materials
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Use with adequate ventilation and store away from oxidizing materials
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Use with adequate ventilation and store away from oxidizing materials
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Use with adequate ventilation and store away from oxidizing materials
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Use with adequate ventilation and store away from oxidizing materials
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Use with adequate ventilation and store away from oxidizing materials
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Use with adequate ventilation and store away from oxidizing materials
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Use with adequate ventilation and store away from oxidizing materials
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Use with adequate ventilation and store away from oxidizing materials
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Use with adequate ventilation and store away from oxidizing materials
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Use with adequate ventilation and store away from oxidizing materials
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Use with adequate ventilation and store away from oxidizing materials
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Use with adequate ventilation and store away from oxidizing materials
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Use with adequate ventilation and store away from oxidizing materials
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Use with adequate ventilation and store away from oxidizing materials
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100859787002024 [Primary]
GS110859787002021 [Package]
Contains: 00859787002024
Package: Box [12 Units]
In Commercial Distribution

FDA Product Code

EBGCrown And Bridge, Temporary, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-10-21

On-Brand Devices [MatrixTemp Temporary Crown and Bridge Material]

10859787002021Self-cure resin based impression material for the fabrication of temporary crowns and bridges
10859787002014Self-cure resin based impression material for the fabrication of temporary crowns and bridges

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