Assure Adhesive Kit AKP

GUDID D798AKP0

The Assure Adhesive system is intended for use as a light cure, hydrophilic bracket adhesive. Because Assure® paste is hydrophilic, it can be applied to a dry or slightly contaminated surface. The smooth cohesive paste viscosity allows for easy application to any style bracket base insuring maximum mechanical retention. Excess flash is easily cleaned from the periphery of the bracket base. Absolutely no bracket flotation regardless of bracket or buccal tube type. The Assure® paste bonds chemically to stainless steel. Kit include Assure® Universal Bonding Resin: Increases adhesion to all normal and atypical enamel situations including hypocalcified, fluorosed, deciduous enamel and dentin. Assure Bonding Resin will bond to roughened metal (amalgam, gold, stainless steel) and composite restorations without additional primers. Furthermore, it is hydrophilic so the etched enamel can be dry or slightly contaminated with saliva. Assure® Bonding Resin does not require drying or light activation. It can be used under any chemical, light cure or dual cure paste regardless of manufacturer. Assure® is a single liquid and paste; no mixing required.

RELIANCE ORTHODONTIC PRODUCTS INC

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• Primary Device ID: D798AKP0
• NIH Device Record Key: 6b61b2f2-d68d-4761-9a28-70b270058fc7
• Commercial Distribution Discontinuation: 2020-02-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Assure Adhesive Kit
• Version Model Number: AKP
• Catalog Number: AKP
• 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: true
• 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
• 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 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798AKP0 [Primary]

FDA Product Code

• DYH: Adhesive, Bracket And Tooth Conditioner, 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: 5
• Public Version Date: 2020-02-27
• Device Publish Date: 2016-07-13

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