Manufacturer registered with FDA
Guangxi Ehall Medical Technology Co.,Ltd
Nanning, China. Lists 13 dental device types with FDA across 1 registered establishment.
- Device types listed
- 13
- Brands and models
- 15
- 510(k) clearances
- 0as applicant
- Markets registered in
- 37 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Guangxi Ehall Medical Technology 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 | Guangxi Ehall Medical Technology Co.,Ltd | 13 device types | — | Below |
| European Union | EUDAMED | Manufacturer | GUANGXI EHALL MEDICAL TECHNOLOGY CO.,LTD | 4 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | GUANGXI EHALL MEDICAL TECHNOLOGY CO., LTD. | 3 | 2020–2020 | 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 Guangxi Ehall Medical Technology 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 |
|---|---|---|---|---|
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Braket, Orthodontic Buccal Tube, Orthodontic Elastic, Orthodontic Arch Wires, Dental Teeth Model,Orthodontic Kit | 2025 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Mixing Tip, Mixing Bowl, Mixing Spatula, Mixing Gun, Mixing pad | 2025 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | Dental Implant Unit | 2026 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | Composite Heater | 2025 |
| Roll CottonEFN · Class 1 | — | Maker | Cotton Roll, Cotton Gauze, Dental Dib, Face Protetive Paper | 2025 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | Prophy cup, Nylon Prophy Brush, Prophy Angle, Proply Motor X1 | 2025 |
| Irrigating (Dental) SyringeEIB · Class 1 | Dental hand instruments | Maker | Painless Anaesthesia Device | 2025 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | Capillary Tip, 3 Way Air Syringe, Air Water Syringe, Saliva EjectorDisposable Irrigation Needle, Irrigation Syringe System, Disposable Dental Syringe, Pre-Bent Needle Tip, | 2025 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Cheek Retractor, Silicone Cheek Retractor | 2025 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Absorbent Paper Points, Gutta Percha Points | 2025 |
| Resin ApplicatorKXR · Class 1 | — | Maker | Micro Applicator, Adhesive Tip | 2025 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Dental Implant Torque Wrench | 2025 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Plastic Sleeve, Barrier Film, Handpiece Sleeve | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Guangxi Ehall Medical Technology 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: Guilin AestheDent Medical Instruments Co., Ltd (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 11 Apr 2025 | K242646 | Dental Implant Unit | Guilin AestheDent Medical Instruments Co., Ltd | EBW Handpiece and Cord Foot Controller |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GUANGXI EHALL MEDICAL TECHNOLOGY CO.,LTDFDA reg. 3036269993 | Nanning Guangxi, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10092754). 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.