Assure AS

GUDID D798AS0

Assure® Universal Bonding Resin is intended to increase adhesion to wet or dry, normal and atypical enamel surfaces including: hypocalcified, fluorosed, deciduous enamel and dentin. It will bond to roughened metal (amalgam, gold or stainless steel) and composite restorations without additional primers. PRODUCT FEATURES: 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.

RELIANCE ORTHODONTIC PRODUCTS INC

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• Primary Device ID: D798AS0
• NIH Device Record Key: b0a1de8b-654b-4e50-9f17-16c4dfac33b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assure
• Version Model Number: AS
• Catalog Number: AS
• 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: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Assure Universal Bonding Resin can be stored and handled at ambient temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Assure Universal Bonding Resin can be stored and handled at ambient temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Assure Universal Bonding Resin can be stored and handled at ambient temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Assure Universal Bonding Resin can be stored and handled at ambient temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Assure Universal Bonding Resin can be stored and handled at ambient temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Assure Universal Bonding Resin can be stored and handled at ambient temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Assure Universal Bonding Resin can be stored and handled at ambient temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Assure Universal Bonding Resin can be stored and handled at ambient temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Assure Universal Bonding Resin can be stored and handled at ambient temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Assure Universal Bonding Resin can be stored and handled at ambient temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Assure Universal Bonding Resin can be stored and handled at ambient temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Assure Universal Bonding Resin can be stored and handled at ambient temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Assure Universal Bonding Resin can be stored and handled at ambient temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Assure Universal Bonding Resin can be stored and handled at ambient temperatures
• Special Storage Condition, Specify: Between 0 and 0 *Assure Universal Bonding Resin can be stored and handled at ambient temperatures

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798AS0 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-29
• Device Publish Date: 2016-06-28

On-Brand Devices [Assure]

• D798AS0: Assure® Universal Bonding Resin is intended to increase adhesion to wet or dry, norm
• D798APP0: Assure paste is intended for use as light cure, hydrophilic bracket adhesive, therefore it can b