FDA UDI In Commercial Distribution 🇺🇸 United States

AirStar

DI: D678AS70X0 · Model: AS70X · AIR TECHNIQUES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
AirStar
Primary DI
D678AS70X0
Version / Model
AS70X
Company Name
AIR TECHNIQUES, INC.
Labeler DUNS
043835081
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-04-25
Public Version
1
Public Version Date
2025-05-05
Public Version Status
New
Public Device Record Key
a9be98d5-6eb1-4e29-9ee7-159d4859ac6e

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
NRD Unit, Operative Dental, Accessories

GMDN Terms

Code Name
31253 Medical device air compressor

Identifiers

Type ID
Primary D678AS70X0
Package D678AS70X1

Customer Contacts