Manufacturer registered with FDA
PSM Medical GmbH
Gunningen, Germany. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 583 registrations outside the US
- Establishments
- 1Germany
Registered in 5 markets
Where regulators' registries name PSM Medical GmbH 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 | PSM Medical GmbH | 8 device types | — | Below |
| European Union | EUDAMED | Manufacturer | PSM Medical GmbH | 56 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | PSM MEDICAL GMBH | 24 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | PSM Medical GmbH | 2 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | PSM MEDICAL GMBH | 1 | — | 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 PSM Medical GmbH 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 Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | — | 2019 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | — | 2019 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | — | 2019 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | — | 2010 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Crown BracketsEconoline BracketsFlair BracketsTriamond Brackets | 2026 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | — | 2010 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | — | 2011 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | — | 2011 |
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
PSM Medical GmbH 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: Psm Medical Solutions (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 14 Dec 2011 | K110392 | PSM LOMAS / BENEFIT SCREWS | Psm Medical Solutions | OAT Orthodontic Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PSM Medical GmbHFDA reg. 3008323540 | Gunningen Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10034286). 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.