Assure Universal Bonding Resin BI4MLAS

GUDID D798BI4MLAS0

Assure® Universal Bonding Resin is hydrophilic so the etched enamel can be dry or slightly contaminated with saliva. Assure® Universal Bonding Resin does not require light activation (except on dentin). It can be used under any chemical, light cure or dual cure paste, regardless of manufacturer. This is the 4 gm volume. .

RELIANCE ORTHODONTIC PRODUCTS INC

Dentine bonding agent/set

• Primary Device ID: D798BI4MLAS0
• NIH Device Record Key: 33c35d43-61ec-4ded-a48b-6d81722dd7c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assure Universal Bonding Resin
• Version Model Number: BI4MLAS
• Catalog Number: BI4MLAS
• Company DUNS: 113170088
• Company Name: RELIANCE ORTHODONTIC PRODUCTS 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: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C / Not to exceed 86 degrees F) or can be refrigerated (2-8 degrees C).

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798BI4MLAS0 [Primary]

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: 2018-09-10
• Device Publish Date: 2018-08-10

On-Brand Devices [Assure Universal Bonding Resin]

• D798BI4MLAS0: Assure® Universal Bonding Resin is hydrophilic so the etched enamel can be dry or slightly cont
• D798AS2ML0: Assure® Universal Bonding Resin is hydrophilic so the etched enamel can be dry or slightly cont
• 00840479200897: BI4MLAS
• 00840479200767: AS