Assure Adhesive Kit

Primary DI
D798AKP0
Brand
Assure Adhesive Kit
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
AKP
Catalog number
AKP
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.
Published
2016-07-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DYHAdhesive, Bracket And Tooth Conditioner, Resin
KLEAgent, Tooth Bonding, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYHAdhesive, Bracket And Tooth Conditioner, ResinDental2
KLEAgent, Tooth Bonding, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D798AKP0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dentine bonding agent/setA material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Assure Paste/Sealant Kit should be stored refrigerated (2-8 Degrees C)

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6307734009paulgropi@aol.com

Regulatory Flags#

DUNS number
113170088
Device count
1
Kit
true

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