AirStar
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…
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.
Who Else Makes It
Concentrated in Guangdong (15), Shanghai (9), Hebei (8). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Shenzhen Senlede Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 33 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Shanghai Greeloy Industry Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 9 |
| Yangzhou Star Oral Care Product Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 7 |
| Dacheng Huaguan Dental Instruments Co., Ltd. | Langfang | Hebei | Contract manufacturer | 4 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
Showing 12 of 65. All 65 manufacturers in China registered for Unit, Operative Dental, Accessories
Record
| Listed by | AIR Techniques, Inc., United States |
|---|---|
| FDA product code | NRD |
| Device type | Unit, Operative Dental, Accessories |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6640 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-01-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Packaging | Box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AS22NEO | In distribution | |
| AS21NEO | In distribution | |
| AS70NEO-INT | In distribution | |
| AS22NEO-INT | In distribution | |
| AS40 | In distribution | |
| AS50NEO-INT | In distribution | |
| ASE600D | In distribution | |
| AS12NEO-INT | In distribution | |
| AS70 | In distribution | |
| ASE220A | In distribution | |
| AS70NEO | In distribution | |
| AS12 | In distribution | |
| AS10C | In distribution | |
| AS70INT | In distribution | |
| ASE450A | In distribution | |
| AS30NEO-INT | In distribution | |
| ASE122D | In distribution | |
| AS21 | In distribution | |
| ASE121D | In distribution | |
| AS22INT | In distribution | |
| AS10NEO | In distribution | |
| AS50X | In distribution | |
| AS50 | In distribution | |
| ASE220D | In distribution | |
| AS40NEO-INT | In distribution | |
| AS30C | In distribution | |
| AS50NEO | In distribution | |
| ASE600A | In distribution | |
| ASE250D | In distribution | |
| AS50INT | In distribution | |
| AS40C | In distribution | |
| AS70X | In distribution | |
| AS21C | In distribution | |
| AS100-1 | In distribution | |
| AS30 | In distribution | |
| AS50CINT | In distribution | |
| AS30NEO | In distribution | |
| ASE250A | In distribution | |
| ASE122A | In distribution | |
| AS10 | In distribution | |
| AS12C | In distribution | |
| AS22 | In distribution | |
| AS50C | In distribution | |
| AS22C | In distribution | |
| AS22CINT | In distribution | |
| ASE450D | In distribution | |
| AS40NEO | In distribution | |
| ASE121A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Plasdent | Plasdent Corp. | 409 |
| Midmark | Midmark Corporation | 106 |
| BaseVac | R.E. Morrison Equipment Inc | 70 |
| Unipack | Unipack LLC | 51 |
| Mojave | AIR Techniques, Inc. | 50 |
| Premium Plus | Premium Plus International Limited | 47 |
| Top Quality Manufacturing | TOP Quality Manufacturing, Inc. | 38 |
| Benco | Benco Dental Supply Co. | 37 |
| Ramvac | Dentalez Alabama, Inc. | 32 |
| VacStar | AIR Techniques, Inc. | 29 |
| Safe Dent | Bgss Company Inc | 22 |
| Atomo | Atomo Dental, Inc. | 21 |
Showing 12 of 107. All products under Unit, Operative Dental, Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K042266 | 2004-08-31 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.