A2

Basic Information

• Brand Name: A2
• Primary DI: D798AO1
• Version / Model: AO
• Catalog Number: AO
• Company Name: RELIANCE ORTHODONTIC PRODUCTS INC
• Labeler DUNS: 113170088
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-07-25
• Public Version: 3
• Public Version Date: 2020-07-10
• Public Version Status: Update
• Public Device Record Key: 2c97e97c-c75b-488b-b381-9c4e9d6d1c50
• Distribution End Date: 2020-07-09

Device Description

A2 Oval Attachment Form can be used for the retention of themoplastic aligners and for horizontal or vertical placement on the tooth depending on the height of the crown.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
KXR	Applicator, Resin	Dental	872.3140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D798AO1	HIBCC
Unit of Use	D798AO0	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at ambient conditions.