Assure Adhesive Kit

Basic Information

• Brand Name: Assure Adhesive Kit
• Primary DI: D798AKP0
• Version / Model: AKP
• Catalog Number: AKP
• Company Name: RELIANCE ORTHODONTIC PRODUCTS INC
• Labeler DUNS: 113170088
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-13
• Public Version: 7
• Public Version Date: 2024-02-16
• Public Version Status: Update
• Public Device Record Key: 6b61b2f2-d68d-4761-9a28-70b270058fc7
• Distribution End Date: 2020-02-26

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	872.3750	2
KLE	Agent, Tooth Bonding, Resin	Dental	872.3200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31750	Orthodontic bracket adhesive	A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.	No	Active
34782	Dentine bonding agent/set	A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D798AKP0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)