Manufacturer registered with FDA
Foshan Gladent Medical Instrument Co.,Ltd.
Foshan, China. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 515 registrations outside the US
- Establishments
- 1China
Registered in 5 markets
Where regulators' registries name Foshan Gladent Medical Instrument 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 | Foshan Gladent Medical Instrument Co.,Ltd. | 5 device types | — | Below |
| European Union | EUDAMED | Manufacturer | FOSHAN GLADENT MEDICAL INSTRUMENT CO., LTD | 12 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Foshan Gladent Medical Instrument Co Ltd | 1 | 2026–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Foshan Gladent Medical Instrument Co., Ltd. | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | FOSHAN GLADENT MEDICAL INSTRUMENT CO., LTD. | 1 | 2023–2023 | 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 Foshan Gladent Medical Instrument 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 NeedleDZM · Class 1 | Dental needles & syringes | Maker | NEEDLE, DENTAL-Dental Burs | 2026 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | — | 2020 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | Dental Unit | 2017 |
| Dental Chair with Operative UnitKLC · Class 1 | Dental chairs & operative units | Maker | Dental Chair With Operative Unit | 2017 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Dental Intraoral camera and Dental air compressor | 2026 |
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
Foshan Gladent Medical Instrument 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: Shanghai Foshion Medical Instruments Co., Ltd. (1), Shanghai Dental Instrument Factory Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 14 Dec 2007 | K071353 | FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C | Shanghai Foshion Medical Instruments Co., Ltd. | KLC Dental Chair with Operative Unit |
| 15 Nov 2006 | K063302 | SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES | Shanghai Dental Instrument Factory Co., Ltd. | EIA Operative Dental Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| FOSHAN GLADENT MEDICAL INSTRUMENT CO.,LTD.FDA reg. 3013237609 | Foshan Guangdong, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10055871). 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.