Duns Number:113170088
Device Description: The Assure Adhesive system is intended for use as a light cure, hydrophilic bracket adhesi 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.
Catalog Number
AKP
Brand Name
Assure Adhesive Kit
Version/Model Number
AKP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 26, 2020
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DYH
Product Code Name
Adhesive, Bracket And Tooth Conditioner, Resin
Public Device Record Key
6b61b2f2-d68d-4761-9a28-70b270058fc7
Public Version Date
July 09, 2020
Public Version Number
6
DI Record Publish Date
July 13, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |