Bisfil 2B A-1253

GUDID 00810111542081

Bisfil 2B Catalyst 5g Syringe

BISCO INC.

Dental composite resin

• Primary Device ID: 00810111542081
• NIH Device Record Key: 7a22df0e-a06d-4130-b083-5473ab9c8b65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bisfil 2B
• Version Model Number: A-1253
• Catalog Number: A-1253
• Company DUNS: 053529939
• Company Name: BISCO INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810111542081 [Primary]
HIBCC	D757A12530 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964000

FDA Product Code

• KLE: AGENT, TOOTH BONDING, RESIN

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-27
• Device Publish Date: 2022-09-19

On-Brand Devices [Bisfil 2B]

• D757A128110: Bisfil 2B A3/A3.5 10g Dual Syringe
• D757A127110: Bisfil 2B Original 10g Dual Syringe
• D757A12530: Bisfil 2B Catalyst 5g Syringe
• D757A12510: Bisfil 2B Base 5g Syringe
• 00810111542081: Bisfil 2B Catalyst 5g Syringe
• 00810111542074: Bisfil 2B Base 5g Syringe
• 00810111542135: Bisfil 2B A3/A3.5 10g Dual Syringe Pkg
• 00810111542098: Bisfil 2B Base & Catalyst 2-5g Syringes each
• 00810111542128: Bisfil 2B A3/A3.5 10g Dual Syringe
• 00810111542111: Bisfil 2B Original 10g Dual Syringe Pkg
• 00810111542104: Bisfil 2B Original 10g Dual Syringe