Uni-Etch w/BAC E-5622EB

GUDID D757E5622EB0

Uni-Etch w/BAC (32% Phosphoric Acid Etchant w/BAC) 5g Syr

BISCO INC.

Dental etching solution
Primary Device IDD757E5622EB0
NIH Device Record Keye98a07ca-0082-4def-89cc-cbb337ccd805
Commercial Distribution StatusIn Commercial Distribution
Brand NameUni-Etch w/BAC
Version Model NumberE-5622EB
Catalog NumberE-5622EB
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
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
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD757E5622EB0 [Primary]

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 Date2022-05-19
Device Publish Date2017-06-12

On-Brand Devices [Uni-Etch w/BAC]

D757E56620Uni-Etch w/BAC (32% Phosphoric Acid Etchant w/BAC) 30ml Syringe
D757E5622EB0Uni-Etch w/BAC (32% Phosphoric Acid Etchant w/BAC) 5g Syr
D757E5502EBM1Uni-Etch w/BAC (32% Phosphoric Acid Etchant w/BAC) 4-Syr Pkg
00810111540971Uni-Etch w/BAC (32% Phosphoric Acid Etchant w/BAC) 4-Syr Pkg
00810111540964Uni-Etch w/BAC (32% Phosphoric Acid Etchant w/BAC) 5g Syr
10810111540992Uni-Etch w/BAC (32% Phosphoric Acid Etchant w/BAC) 30ml Syringe
00810111540988Uni-Etch w/BAC (32% Phosphoric Acid Etchant w/BAC) 30gm Btl Pkg

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