Assure Adhesive Kit

FDA UDI

Class II (US FDA UDI)

by Reliance Orthodontic Products, Inc.

Identity

Trade Name: Assure Adhesive Kit FDA UDI
Generic Name: Dentine bonding agent/set FDA UDI
Device Name: 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. FDA UDI
Model / Reference: AKP FDA UDI
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. FDA UDI

Identifiers

Catalog Number: AKP FDA UDI
Primary DI / UDI-DI: D798AKP0 FDA UDI
FDA Product Code: DYH FDA UDI
KLE FDA UDI
GMDN Term: Dentine bonding agent/set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3750 FDA UDI
872.3200 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Assure Adhesive Kit by Reliance Orthodontic Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Reliance Orthodontic Products, Inc.

Sources (1)

FDA UDI 6b61b2f2-d68d-4761-9a28-70b270058fc7 37 fields · synced May 30, 2026