Data / Medical devices / Germany / PSM Medical GmbH
PSM Medical GmbH: FDA-registered device maker in Gunningen Baden-Wurttemberg, Germany, 1 510(k) clearance
PSM Medical GmbH is registered with the FDA (registration 3008323540) in Gunningen Baden-Wurttemberg, Germany. It lists 12 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 14, 2011. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008323540
- Address
- Gewerbestr. 10, Gunningen Baden-Wurttemberg, Germany, 78594
- Owner or operator
- PSM Medical GmbH (10034286)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 19, 2010
- Registered through
- 2026
- Brand names listed
- Crown Brackets, Econoline Brackets, Flair Brackets, Triamond Brackets
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Manufacturer | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Manufacturer | accessdata.fda.gov |
| Forceps | HTD | 1 | Manufacturer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Orthodontic | OAT | 2 | Manufacturer | accessdata.fda.gov |
| Retainer, Screw Expansion, Orthodontic | DYJ | 1 | Manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Manufacturer | accessdata.fda.gov |
| Spring, Orthodontic | ECO | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Orthodontic | DZD | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 14, 2011 | K110392 | PSM LOMAS / BENEFIT SCREWS | OAT | Substantially Equivalent | Psm Medical Solutions | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Forceps
- All makers of Implant, Endosseous, Orthodontic
- All makers of Retainer, Screw Expansion, Orthodontic
- All makers of Tray, Surgical
- All makers of Handle, Instrument, Dental
Updated December 14, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.