Manufacturer registered with FDA
Duerr Dental SE
Melville, NY, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 14 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 22
- 510(k) clearances
- 141995–2019
- Markets registered in
- 12199 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Registered in 12 markets
Where regulators' registries name Duerr Dental SE as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Duerr Dental SE | 14 clearances | 1995–2019 | Below |
| Canada | Health Canada | Registration holder | AIR TECHNIQUES INC. | 77 | 1998–2023 | Pure Global AI |
| Colombia | INVIMA | Registration holder | AIR TECHNIQUES INC | 44 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Air Techniques IncAIR TECHNIQUES, INC. | 14 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Air Techniques, Inc. | 14 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Air Techniques, Inc. | 12 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | AIR TECHNIQUES, INC.Air Techniques Inc. · AIR TECHNIQUES INC. | 12 | 2006–2023 | Pure Global AI |
| Australia | TGA | Manufacturer | Air Techniques Inc | 9 | 2020–2022 | Pure Global AI |
| Israel | AMAR | Manufacturer | Air Techniques Inc.Air Techniques, Inc. · AIR TECHNIQUES , INC. · +1 | 7 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Air TechniquesAir Techniques, Inc. | 5 | 2001–2010 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | AIR TECHNIQUES, INC | 4 | 2015–2020 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Air Techniques, Inc. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Duerr Dental SE currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | ScanX Duo -D1000A, D1000J, D1000T, D1000KScanX Duo Touch: J1200ScanX Intraoral - F3605, F3600TScanX Swift - G8000VistaScan Ultra View: J1300 (2170110001) | 2007 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | AirStar - AS10, AS10C, AS12, AS12C, AS21, AS21C, AS22, AS22C, AS30, AS30C, AS40, AS40C, AS50, AS50C, AS70, AS100AirStar Clinical Air Compressor - AS60, AS90, AS120, AS60C, AS90C, AS120CAirStar ECO - ASE121A, ASE121D, ASE122A, ASE122D, ASE220A, ASE220D, ASE250A, ASE250D, ASE450A, ASE450D,ASE600A, ASE600DAirStar INT - AS22INT, AS22CINT, AS50INT, AS50CINT, AS70INTAirStar NEO International -AS12NEO-INT, AS22NEO-INT, AS30NEO-INT, AS40NEO-INT, AS50NEO-INT and AS70NEO-INTAirStar NEO- AS10NEO, AS21NEO, AS22NEO, AS30NEO, AS40NEO, AS50NEO, AS70NEOAirStar Preventive Maintenance Kit - 87351, 87352, 87353, 87354, 87355AirStar Remote Air Intake - 85491, 85492, 85493, 85494, 87361AirStar Remote Control Panel - 53111, 53133, 53250, 53251AirStar Sound Cover - 85961, 85962-1M, 85962-2M, 85963M, 87440M, 89523M, 89574M, 85180 7 moreMojave - CT12, CT20, CT34, MT10, MT12, H5200, H5280, H5223, H5225, H5635, H5480Mojave - V3PUMP, V5PUMP, V7PUMP, V15PUMP, MMC, V3MPUMP, V5MPUMP, V7MPUMP, V15MPUMP, MMC-MMojave LT - LT3, LT3M, LT5, LT5MVacStar - VS20, VS40, VS50, VS50H, VS80, VS80HVacStar Clinical Dry Vacuum Systems - VS60, VS90, VS120VacStar Hydromiser - H-2, H-4, 56041, 56042VacStar NEO - VS20NEO, VS40NEO, VS50NEO, VS80NEO | 2004 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Duerr Dental SE as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 21 Aug 2019 | K191623 | ScanX Touch/ScanX Duo Touch | MUH Digital Extraoral Source X-Ray System |
| 18 Aug 2009 | K090169 | SPECTRA FLUORESCENCE CARIES DETECTION DEVICE | NBL Light-Induced Fluorescence Caries Detector |
| 26 May 2006 | K052271 | RINSENDO | NYL Root Canal Irrigation Air-Powered Handpiece |
| 26 May 2005 | K050693 | ACCENT | MUH Digital Extraoral Source X-Ray System |
| 31 Aug 2004 | K042266 | ACCLAIM | NRD Accessories Operative Dental Unit |
| 16 Apr 2003 | K024285 | A/T X-RAY 70 | EHD Extraoral with Timer X-Ray Unit |
| 1 Feb 2002 | K013893 | SCANX | MUH Digital Extraoral Source X-Ray System |
| 21 Dec 2000 | K002122 | VECTOR | ELC Ultrasonic Scaler |
| 22 Mar 1999 | K984584 | AIR TECHNIQUES' DENTO-VAC | EIA Operative Dental Unit |
| 24 Sep 1998 | K981564 | AIR TECHNIQUES' AIRDENT II | KOJ Airbrush |
| 24 Aug 1998 | K982615 | AIRDENT RADIANCE CURING LIGHT | EBZ Ultraviolet Activator for Polymerization |
| 8 Jan 1998 | K974204 | VISTACAM OMNI AND VIASTCAM OMNI (IC) | EIA Operative Dental Unit |
| 17 Mar 1995 | K942698 | VACSTAR | EIA Operative Dental Unit |
| 16 Mar 1995 | K943204 | VISTACAM | EIA Operative Dental Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| AIR TECHNIQUES, INC.FDA reg. 2428225 | Melville, NY, United States | Manufacturer, Specification developer |
Other names on FDA records
Air Techniques, Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2428225). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.