A2

Basic Information

• Brand Name: A2
• Primary DI: D798A20
• Version / Model: A2
• Catalog Number: A2
• 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: 2016-07-25
• Public Version: 3
• Public Version Date: 2024-02-16
• Public Version Status: Update
• Public Device Record Key: 9a1f6d38-02c2-4840-b76a-ae3356b3b5b7
• Distribution End Date: 2017-09-07

Device Description

The aligner attachment kit is intended for use in the creation of molds for thermoplastic alligners. The Oval Attachment Form can be used for the retention of the thermoplastic aligners and for horizontal or vertical placement on the tooth depending on the height of the crown. The Rectangle Attachment Form can be used for individual tooth movement and for extrusion of teeth. The Assure Bonding Resin included will bond to all intraoral surfaces without additional primers. L.C.R. Light Cure Paste cures smooth as glass for patient comfort. It has a very high Barcol Hardness for long term durability.

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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KLE	Agent, Tooth Bonding, Resin	Dental	872.3200	2
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	872.3760	2
KXR	Applicator, Resin	Dental	872.3140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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
42344	Dental mould	A hollow form in which a dental material is intended to be injected, cast, or pressed to produce a particular shape.	No	Active
44732	Orthodontic aligner auxiliary attachment kit	A collection of devices, used with retainer-style orthodontic appliances (e.g., preformed teeth aligners) to further facilitate and enhance teeth alignment. The kit includes buttons and elastics, typically made of clear materials for aesthetic purposes, that are attached to the orthodontic aligner and/or teeth to help achieve extrusion, rotation and anchorage control. This provides the clinician with greater control to achieve additional tooth movement during the treatment. The contents of this kit may also include plastic/composite adhesive, etchant, elastics, burs and polishing wheels for cutting the aligners. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D798A20	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature