Data / Medical devices / Switzerland / Edelweissdr AG
Edelweissdr AG: FDA-registered device maker in Zug, Switzerland, 1 510(k) clearance
Edelweissdr AG is registered with the FDA (registration 3011148229) in Zug, Switzerland. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 30, 2008. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011148229
- Address
- Unter Altstadt 28 Mercandor, Zug, Switzerland, 6300
- Owner or operator
- EdelweissDR AG (10047324)
- Roles
- Repackager or relabeler
- First device listed
- August 8, 2014
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Tooth Bonding, Resin | KLE | 2 | Repackager or relabeler | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| May 30, 2008 | K080480 | NANOCOMPOSITE RESTORATIVE KIT | EBF | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 30, 2008. 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.