Choice 2 Try-In Paste C-412A1

GUDID 00810111540636

Choice 2 Try-In Paste A1 2g Syringe

BISCO INC.

Dental cement trial
Primary Device ID00810111540636
NIH Device Record Key2fd9e1bf-bc2c-4755-a1cc-ace70582bb74
Commercial Distribution StatusIn Commercial Distribution
Brand NameChoice 2 Try-In Paste
Version Model NumberC-412A1
Catalog NumberC-412A1
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 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+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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810111540636 [Primary]
HIBCCD757C412A10 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2022-08-09
Device Publish Date2022-08-01

On-Brand Devices [Choice 2 Try-In Paste]

D757C412TRP1Choice 2 Try-In Paste Translucent 2g Syringe Pkg
D757C412TR0Choice 2 Try-In Paste Translucent 2g Syringe
D757C412OPP1Choice 2 Try-In Paste Opaque 2g Syringe Pkg
D757C412OP0Choice 2 Try-In Paste Opaque 2g Syringe
D757C412MOP1Choice 2 Try-In Paste Milky Opaque 2g Syringe Pkg
D757C412MO0Choice 2 Try-In Paste Milky Opaque 2g Syringe
D757C412MBP1Choice 2 Try-In Paste Milky Bright 2g Syringe Pkg
D757C412MB0Choice 2 Try-In Paste Milky Bright 2g Syringe
D757C412B1P1Choice 2 Try-In Paste B1 2g Syringe Pkg
D757C412B10Choice 2 Try-In Paste B1 2g Syringe
D757C412A3P1Choice 2 Try-In Paste A3 2g Syringe Pkg
D757C412A30Choice 2 Try-In Paste A3 2g Syringe
D757C412A2P1Choice 2 Try-In Paste A2 2g Syringe Pkg
D757C412A20Choice 2 Try-In Paste A2 2g Syringe
D757C412A1P1Choice 2 Try-In Paste A1 2g Syringe Pkg
D757C412A10Choice 2 Try-In Paste A1 2g Syringe
00810111540780Choice 2 Try-In Paste Translucent 2g Syringe Pkg
00810111540773Choice 2 Try-In Paste Translucent 2g Syringe
00810111540766Choice 2 Try-In Paste Opaque 2g Syringe Pkg
00810111540759Choice 2 Try-In Paste Opaque 2g Syringe
00810111540742Choice 2 Try-In Paste Milky Opaque 2g Syringe Pkg
00810111540735Choice 2 Try-In Paste Milky Opaque 2g Syringe
00810111540728Choice 2 Try-In Paste Milky Bright 2g Syringe Pkg
00810111540711Choice 2 Try-In Paste Milky Bright 2g Syringe
00810111540667Choice 2 Try-In Paste A2 2g Syringe Pkg
00810111540650Choice 2 Try-In Paste A2 2g Syringe
00810111540643Choice 2 Try-In Paste A1 2g Syringe Pkg
00810111540636Choice 2 Try-In Paste A1 2g Syringe
00810111540674Choice 2 Try-In Paste A3 2g Syringe
00810111540704Choice 2 Try-In Paste B1 2g Syringe Pkg
00810111540698Choice 2 Try-In Paste B1 2g Syringe
00810111540681Choice 2 Try-In Paste A3 2g Syringe Pkg
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.