AirStar

Basic Information

• Brand Name: AirStar
• Primary DI: D678AS22NEO0
• Version / Model: AS22NEO
• Company Name: AIR TECHNIQUES, INC.
• Labeler DUNS: 043835081
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-04
• Public Version: 1
• Public Version Date: 2023-01-12
• Public Version Status: New
• Public Device Record Key: 581d0cc5-6fd8-4ad2-aa78-9ca90bcf7ba0

Device Description

AirStar® Dental Air Systems (AirStar®, AirStar® Monitor & AirStar® ECO) generate 100% oil-free, dry air which protects valuable hand pieces from premature failure due to the effects of moist air and the build-up of oil residue. Because no oil is used for mechanical lubrication, there is no chance of introducing an oily film to a prepared surface which could compromise resin retention and restorations, wasting chair time. Most important, patient’s health is protected with dry air that provides an environment that is not conducive to bacterial growth.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
NRD	Unit, Operative Dental, Accessories	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31253	Medical device air compressor	A mains electricity (AC-powered) device designed to create compressed air and supply it directly to gas-powered or compressed air dependent devices (e.g., ventilators or other respiratory devices, laboratory equipment). It may also provide medical air depending upon the filtering systems employed.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D678AS22NEO1	HIBCC	Box	1	In Commercial Distribution
Primary	D678AS22NEO0	HIBCC

Customer Contacts

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