Etch-37 w/BAC E-5638EB

GUDID 00810111541060

Etch-37 w/BAC (37% Phosphoric Acid Etchant w/BAC) 30gm Btl Pkg

BISCO INC.

Dental etching solution
Primary Device ID00810111541060
NIH Device Record Key9ce0690b-5e5f-40d8-9e0b-fe019ec5c069
Commercial Distribution StatusIn Commercial Distribution
Brand NameEtch-37 w/BAC
Version Model NumberE-5638EB
Catalog NumberE-5638EB
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
GS100810111541060 [Primary]
HIBCCD757E5638EB1 [Previous]

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

On-Brand Devices [Etch-37 w/BAC]

D757E56740Etch-37 w/BAC (37% Phosphoric Acid Etchant w/BAC) 30ml Syringe
D757E5623EB0Etch-37 w/BAC (37% Phosphoric Acid Etchant w/BAC) 5g Syringe
D757E5503EBM1Etch-37 w/BAC (37% Phosphoric Acid Etchant w/BAC) 4-Syr Pkg
00810111541053Etch-37 w/BAC (37% Phosphoric Acid Etchant w/BAC) 4-Syr Pkg
00810111541046Etch-37 w/BAC (37% Phosphoric Acid Etchant w/BAC) 5g Syringe
00810111541077Etch-37 w/BAC (37% Phosphoric Acid Etchant w/BAC) 30ml Syringe
00810111541060Etch-37 w/BAC (37% Phosphoric Acid Etchant w/BAC) 30gm Btl Pkg

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.