Aeliteflo H-671A2OF

GUDID D757H671A2OF1

AELITEFLO Composite A2O Syr.

BISCO INC.

Dental composite resin

• Primary Device ID: D757H671A2OF1
• NIH Device Record Key: 494ed70e-783d-408b-8bbb-c3b7f0b6a9db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aeliteflo
• Version Model Number: H-671A2OF
• Catalog Number: H-671A2OF
• 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: true
• 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
• 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
• 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
• 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
• 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
• 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
• 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
HIBCC	D757H671A2OF1 [Primary]

FDA Product Code

• EID: SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-05-18
• Device Publish Date: 2017-06-12

On-Brand Devices [Aeliteflo]

• D757H675TIF1: AELITEFLO Composite Tran. Syr.
• D757H675TI0: AELITEFLO L/C Comp Tr 1.5gm
• D757H675OWF1: AELITEFLO Composite W-Op. Syr.
• D757H675OW0: AELITEFLO L/C Comp W-O 1.5gm
• D757H674D3F1: AELITEFLO Composite D3 Syr.
• D757H674D30: AELITEFLO L/C Comp D3 1.5gm
• D757H673C3F1: AELITEFLO Composite C3 Syr.
• D757H673C30: AELITEFLO L/C Comp C3 1.5gm
• D757H673C2F1: AELITEFLO Composite C2 Syr.
• D757H673C20: AELITEFLO L/C Comp C2 1.5gm
• D757H672B1F1: AELITEFLO Composite B1 Syr.
• D757H671A5F1: AELITEFLO Composite A5 Syr.
• D757H671A50: AELITEFLO L/C Comp A5 1.5gm
• D757H671A3F1: AELITEFLO Composite A3 Syr.
• D757H671A35F1: AELITEFLO Composite A3.5 Syr.
• D757H671A350: AELITEFLO L/C Comp A3.5 1.5gm
• D757H671A30: AELITEFLO L/C Comp A3 1.5gm
• D757H671A2OF1: AELITEFLO Composite A2O Syr.
• D757H671A2O0: AELITEFLO Composite A2O 1.5gm
• D757H671A2F1: AELITEFLO Composite A2 Syr.
• D757H671A20: AELITEFLO L/C Comp A2 1.5gm
• D757H671A1F1: AELITEFLO Composite A1 Syr.
• D757H671A10: AELITEFLO L/C Comp A1 1.5gm
• D757H672B10: AELITEFLO L/C Comp B1 1.5gm
• 00810111540209: AELITEFLO Composite A3 Syr.
• 00810111540193: AELITEFLO L/C Comp A3 1.5gm
• 00810111540162: AELITEFLO Composite A2 Syr.
• 00810111540155: AELITEFLO L/C Comp A2 1.5gm
• 00810111540148: AELITEFLO Composite A1 Syr.
• 00810111540346: AELITEFLO Composite White Opaque. Syr. Package
• 00810111540278: AELITEFLO L/C Comp C2 1.5gm
• 00810111540360: AELITEFLO Composite Tran. Syr.
• 00810111540285: AELITEFLO Composite C2 Syr. Pkg
• 00810111540254: AELITEFLO L/C Comp B1 1.5gm
• 00810111540223: AELITEFLO Composite A3.5 Syr. Pkg
• 00810111540216: AELITEFLO L/C Comp A3.5 1.5gm
• 00810111540131: AELITEFLO L/C Comp A1 1.5gm
• 00810111540353: AELITEFLO L/C Comp Tr 1.5gm
• 00810111540261: AELITEFLO Composite B1 Syr.
• 00810111540179: AELITEFLO Composite A2O 1.5gm
• 00810111540186: AELITEFLO Composite A2O Syr.
• 00810111540339: AELITEFLO L/C Composite Opaque White 1.5gm
• 00810111540322: AELITEFLO Composite D3 Syr.