DEVICE: AirStar (D678AS30C0)

Device Identifier (DI) Information

AirStar
AS30C
In Commercial Distribution

AIR TECHNIQUES, INC.
D678AS30C0
HIBCC

1
043835081 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NRD Unit, Operative Dental, Accessories
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

b5917b46-e251-493c-884b-3e4073c3897c
January 11, 2023
1
January 03, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
D678AS30C1 1 D678AS30C0 In Commercial Distribution Box
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1 (516) 214-5512
mardonio.nicolas@airtechniques.com
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