Ace Universal Primer A&B Cartridge-Pouch B-41201

GUDID D757B412010

BISCO INC.

Dentine bonding agent/set
Primary Device IDD757B412010
NIH Device Record Keyfee4d09b-cb71-4619-b740-f6ec2df78a6f
Commercial Distribution Discontinuation2019-03-05
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAce Universal Primer A&B Cartridge-Pouch
Version Model NumberB-41201
Catalog NumberB-41201
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD757B412010 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2024-02-16
Device Publish Date2017-06-15

Devices Manufactured by BISCO INC.

00810111543323 - Quantium2025-08-06 Quantium A2 Body 1g Syringe
00810111543330 - Quantium2025-08-06 Quantium A2 Enamel 1g Syringe
00810111543347 - Quantium2025-08-06 Quantium A2 Body & A2 Enamel Syringe (1g each) Sample Package
10810111541500 - Aelite Aesthetic Enamel2025-07-30 Aelite Aesthetic Enamel B4 Syringe
10810111541548 - Aelite Aesthetic Enamel2025-07-30 Aelite Aesthetic Enamel Incisal Frost Syringe
10810111542255 - eCement2025-07-30 eCement LC A1 4.5g Syringe
20810111541606 - Aelite Aesthetic Enamel2025-07-30 Aelite Aesthetic Enamel A4 15ct Unit Dose (0.25g ea)
20810111541637 - Aelite Aesthetic Enamel2025-07-30 Aelite Aesthetic Enamel B3 15ct Unit Dose (0.25g ea)

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.