Manufacturer registered with FDA
DTR Medical Ltd
Swansea, United Kingdom. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 6100 registrations outside the US
- Establishments
- 1United Kingdom
Registered in 6 markets
Where regulators' registries name DTR Medical 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 | DTR Medical Ltd | 3 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | DTR Medical Ltd | 66 | — | Pure Global AI |
| Australia | TGA | Manufacturer | DTR Medical Ltd | 23 | 2009–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | DTR MEDICAL LTD | 8 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | DTR Medical Ltd | 2 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | DTR Medical Ltd | 1 | 2025–2025 | 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 DTR Medical 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 Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | College Dental Forceps | 2025 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | Dental Syringes | 2023 |
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Maker | Oral Rotating Biopsy Punch | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DTR MEDICAL LTDFDA reg. 3008280196 | Swansea, United Kingdom | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10083093). 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.