Manufacturer registered with FDA
Guangzhou Ajax Medical Equipment Co., Ltd.
Guangzhou, China. Lists 7 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 7
- Brands and models
- 20
- 510(k) clearances
- 12026–2026
- Markets registered in
- 1331 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 13 markets
Where regulators' registries name Guangzhou Ajax Medical Equipment Co., Ltd. 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 | Guangzhou Ajax Medical Equipment Co., Ltd. | 1 clearances | 2026–2026 | Below |
| European Union | EUDAMED | Manufacturer | Guangzhou Ajax Medical Equipment Co., Ltd. | 7 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Guangzhou Ajax Medical Equipment Co., Ltd.Guangzhou Ajax Medical Equipment Ltd | 5 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Guangzhou Ajax Medical Equipment Co Ltd | 3 | 2016–2016 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | GUANGZHOU AJAX MEDICAL EQUIPMENT CO., LTD | 3 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Guangzhou Ajax Medical Equipment Co Ltd | 3 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | GUANGZHOU AJAX MEDICAL EQUIPMENT CO., LTDGuangzhou Ajax Medical Equipment Co., Ltd | 2 | 2017–2017 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | GUANGZHOU AJAX MEDICAL EQUIPMENT CO., LTD.Guangzhou Ajax Medical Equipment Co., Ltd. | 2 | 2017–2026 | Pure Global AI |
| Tanzania | TMDA | Manufacturer | Guangzhou Ajax Medical Equipment Co., Ltd | 2 | 2026–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | GUANGZHOU AJAX MEDICAL EQUIPMENT CO., LTD. | 1 | 2025–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Guangzhou AJAX Medical Equipment Co., Ltd | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | GUANGZHOU AJAX MEDICAL EQUIPMENT CO., LTD | 1 | 2022–2022 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Guangzhou Ajax Medical Equipment Co., Ltd. | 1 | 2024–2024 | 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 Guangzhou Ajax Medical Equipment Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | LED Dental Light(model: Amber, Amber II, Pebble, Pebble II, Hubble, Hubble II, Leo, Libra, Whale) | 2019 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | Suction System, Dry Vaccum System (model: SP1000,SP3000,SP3000+,SP5000,SP5000+,ADS V3, ADS V5, ADS V7,ADS V10, ADS V14)Suction System, Dry Vaccum System(model: DV600,DV800,DV1000,DV1500)Suction System, Dry Vaccum System(model: SV300,SV400,SV600,SV800,SV1000,PV100,V20,V40,V60,V80,V100)Suction System, Dry Vaccum System(model: WV200,WV400,WV600) | 2020 |
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | Dental X-RAY Unit(Model:AJX200, AJX100, AJX300, AJX400, AJX500, AJX600, AJX700) | 2026 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | Beyond 300 Continental, Beyond 400 ContinentalClassic 100,Classic 101,Classic 200,Classic 201,Beyond 300,Beyond 301,Beyond 400,Beyond 401Dental Unit(model:AJ10;AJ11;AJ12;AJ15;AJ16;AJ17;AJ18;AJ19;AJ22;AJ25;AJ26;AJ28,AJ21,AJ27)Mobile CartPortable Delivery SystemSelf Contained Enlarged Orthodontic Mobile Cart OC-2ultima 800, ultima 801 | 2014 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | Intraoral Scanner(Model: AJS1, AJS2, AJS3) | 2025 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Oil Free Air Compressor(model: AJAX100;AJAX200;AJAX300;AJAX400;AJAX600;AJAX800;AJAX1000)Oil Free Air Compressor(model: UA200;UA300;UA400;UA600;UA900;UA1000;UA1200;AT800;BA800;AT20P;AT40P;AT60P;AT80P;AT100P)Oil Free Air Compressor(model:BA100;BA200;BA220;BA300;BA400;BA600;BA1000;BA1200;AT200;AT260;AT300;AT400;AT600;AT1000)Suction System, Dry Vaccum System (model: SP1000,SP3000,SP3000+,SP5000,SP5000+,ADS V3, ADS V5, ADS V7,ADS V10, ADS V14)Suction System, Dry Vaccum System(model: SV300,SV400,SV600,SV800,SV1000,PV100) | 2019 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Dental Chair, Dental Stool | 2019 |
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 Guangzhou Ajax Medical Equipment Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 12 Mar 2026 | K252110 | Dental X-RAY Unit (AJX200) | EHD Extraoral with Timer X-Ray Unit |
Some of these clearances are listed with FDA today by another company: Ads Dental System Inc. (1).
Also lists devices cleared under other names
Guangzhou Ajax Medical Equipment Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Pro Dental Services, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 5 Sep 2014 | K132245 | AJAX DENTAL UNIT | Pro Dental Services, LLC | EIA Operative Dental Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GUANGZHOU AJAX MEDICAL EQUIPMENT CO LTDFDA reg. 3010446656 | Guangzhou Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048168). 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.