Data / Medical devices / United States / Air Techniques, Inc.
Air Techniques, Inc.: FDA-registered device maker in Melville, NY, United States, 3 510(k) clearances
Air Techniques, Inc. is registered with the FDA (registration 2428225) in Melville, NY, United States. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 21, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2428225
- Address
- 1295 Walt Whitman Rd, Melville, NY, United States, 11747
- Owner or operator
- DUERR DENTAL SE (2428225)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 8, 2004
- Registered through
- 2026
- Brand names listed
- AirStar - AS10, AS10C, AS12, AS12C, AS21, AS21C, AS22, AS22C, AS30, AS30C, AS40, AS40C, AS50, AS50C, AS70, AS100, AirStar Clinical Air Compressor - AS60, AS90, AS120, AS60C, AS90C, AS120C, AirStar ECO - ASE121A, ASE121D, ASE122A, ASE122D, ASE220A, ASE220D, ASE250A, ASE250D, ASE450A, ASE450D,ASE600A, ASE600D, AirStar INT - AS22INT, AS22CINT, AS50INT, AS50CINT, AS70INT, AirStar NEO International -AS12NEO-INT, AS22NEO-INT, AS30NEO-INT, AS40NEO-INT, AS50NEO-INT and AS70NEO-INT, AirStar NEO- AS10NEO, AS21NEO, AS22NEO, AS30NEO, AS40NEO, AS50NEO, AS70NEO, AirStar Preventive Maintenance Kit - 87351, 87352, 87353, 87354, 87355, AirStar Remote Air Intake - 85491, 85492, 85493, 85494, 87361 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dental Barriers And Sleeves | PEM | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Film, Radiographic | IWZ | 1 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Manufacturer | accessdata.fda.gov |
| Tube Mount, X-Ray, Diagnostic | IYB | 1 | Manufacturer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 21, 2019 | K191623 | ScanX Touch/ScanX Duo Touch | MUH | Substantially Equivalent | Air Techniques, Inc. | accessdata.fda.gov |
| July 26, 2019 | K190949 | ScanX Barrier Envelopes | PEM | Substantially Equivalent | Air Techniques, Inc. | accessdata.fda.gov |
| February 1, 2002 | K013893 | SCANX | MUH | Substantially Equivalent | Air Techniques, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Operative Dental, Accessories
- All makers of System, X-Ray, Extraoral Source, Digital
- All makers of Film, Radiographic
- All makers of Tubing, Pressure And Accessories
- All makers of Dental Barriers And Sleeves
- All makers of Tube Mount, X-Ray, Diagnostic
Updated August 21, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.