Choice 2 C-39010K

GUDID 00810111540629

Choice 2 Starter Kit with All-Bond Universal

BISCO INC.

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Primary Device ID00810111540629
NIH Device Record Keyc94a8f1e-0862-47a7-8d18-ced79b8ed9a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameChoice 2
Version Model NumberC-39010K
Catalog NumberC-39010K
Company DUNS053529939
Company NameBISCO 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

Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com
Phone+1(847)534-6000
Emailsales@bisco.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810111540629 [Primary]
HIBCCD757C39010K1 [Previous]

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 Date2022-10-19
Device Publish Date2022-10-11

On-Brand Devices [Choice 2]

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D757C411TR0Choice 2 Veneer Cement Translucent 4.5g Syringe
D757C411OPP1Choice 2 Veneer Cement Opaque Syringe Pkg
D757C411OP0Choice 2 Veneer Cement Opaque 4.5g Syringe
D757C411MOP1Choice 2 Veneer Cement Milky Opaque Syringe Pkg
D757C411MO0Choice 2 Veneer Cement Milky Opaque 4.5g Syringe
D757C411MBP1Choice 2 Veneer Cement Milky Bright Syringe Pkg
D757C411MB0Choice 2 Veneer Cement Milky Bright 4.5g Syringe
D757C411B1P1Choice 2 Veneer Cement B1 Syringe Pkg
D757C411B10Choice 2 Veneer Cement B1 4.5g Syringe
D757C411A3P1Choice 2 Veneer Cement A3 Syringe Pkg
D757C411A30Choice 2 Veneer Cement A3 4.5g Syringe
D757C411A2P1Choice 2 Veneer Cement A2 Syringe Pkg
D757C411A20Choice 2 Veneer Cement A2 4.5g Syringe
D757C411A1P1Choice 2 Veneer Cement A1 Syringe Pkg
D757C411A10Choice 2 Veneer Cement A1 4.5g Syringe
10810111540596Choice 2 Veneer Cement Translucent Syringe Pkg
10810111540572Choice 2 Veneer Cement Milky Opaque Syringe Pkg
10810111540565Choice 2 Veneer Cement Milky Bright Syringe Pkg
10810111540558Choice 2 Veneer Cement B1 Syringe Pkg
10810111540534Choice 2 Veneer Cement A2 Syringe Pkg
10810111540527Choice 2 Veneer Cement A1 Syringe Pkg
00810111540599Choice 2 Veneer Cement Translucent 4.5g Syringe
00810111540575Choice 2 Veneer Cement Milky Opaque 4.5g Syringe
00810111540568Choice 2 Veneer Cement Milky Bright 4.5g Syringe
00810111540551Choice 2 Veneer Cement B1 4.5g Syringe
00810111540537Choice 2 Veneer Cement A2 4.5g Syringe
00810111540520Choice 2 Veneer Cement A1 4.5g Syringe
00810111540605Choice 2 Starter Kit
00810111540612CHOICE 2 Starter Kit EU
00810111540629Choice 2 Starter Kit with All-Bond Universal
10810111540541Choice 2 Veneer Cement A3 4.5g Syringe
10810111540589Choice 2 Veneer Cement Opaque 4.5g Syringe
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