Bisfil 2B A-1254P

GUDID 00810111542098

Bisfil 2B Base & Catalyst 2-5g Syringes each

BISCO INC.

Dental composite resin
Primary Device ID00810111542098
NIH Device Record Keydef556d6-254f-4522-9f9f-76a148d6df3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBisfil 2B
Version Model NumberA-1254P
Catalog NumberA-1254P
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
GS100810111542098 [Primary]
HIBCCD757A1254P1 [Previous]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-18
Device Publish Date2022-10-10

On-Brand Devices [Bisfil 2B]

D757A128110Bisfil 2B A3/A3.5 10g Dual Syringe
D757A127110Bisfil 2B Original 10g Dual Syringe
D757A12530Bisfil 2B Catalyst 5g Syringe
D757A12510Bisfil 2B Base 5g Syringe
00810111542081Bisfil 2B Catalyst 5g Syringe
00810111542074Bisfil 2B Base 5g Syringe
00810111542135Bisfil 2B A3/A3.5 10g Dual Syringe Pkg
00810111542098Bisfil 2B Base & Catalyst 2-5g Syringes each
00810111542128Bisfil 2B A3/A3.5 10g Dual Syringe
00810111542111Bisfil 2B Original 10g Dual Syringe Pkg
00810111542104Bisfil 2B Original 10g Dual Syringe

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