Manufacturer registered with FDA
Foshan Topmed Dental Co., Ltd.
Foshan, China. Lists 2 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 4
- 510(k) clearances
- 22026–2026
- Markets registered in
- 33 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Foshan Topmed Dental 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 Topmed Dental Co., Ltd. | 2 clearances | 2026–2026 | Below |
| European Union | EUDAMED | Manufacturer | Foshan Topmed Dental Co., Ltd | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | FOSHAN TOPMED DENTAL CO., LTD. | 1 | 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 Foshan Topmed Dental 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 Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | Dental air-motor handpiece(TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)High speed air turbine handpiece (TM-T1B2, TM-T1M4, TM-T2B2, TM-T2M4, TM-T3B2, TM-T3M4, TM-T4B2,TM-T4M4, TM-T6B2, TM-T6M4) | 2026 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | Dental air-motor handpiece(TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) | 2026 |
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 Foshan Topmed Dental Co., Ltd. as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| FOSHAN TOPMED DENTAL CO., LTD.FDA reg. 3018197668 | Foshan Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10095950). 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.