Data / Medical devices / Austria / Edelweiss Dentistry Products GMBH
Edelweiss Dentistry Products GMBH: FDA-registered device maker in Wolfurt Vorarlberg, Austria, 1 510(k) clearance
Edelweiss Dentistry Products GMBH is registered with the FDA (registration 3009117991) in Wolfurt Vorarlberg, Austria. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 18, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009117991
- Address
- Dammstrasse 68, Wolfurt Vorarlberg, Austria, 6922
- Owner or operator
- edelweiss dentistry products gmbh (10036346)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- May 3, 2011
- Registered through
- 2027
- Brand names listed
- Ceramir CAD/CAM C-BLOCK A0, Ceramir CAD/CAM C-BLOCK A1, Ceramir CAD/CAM C-BLOCK A2, Ceramir CAD/CAM C-BLOCK A3, Ceramir CAD/CAM T-BLOCK Universal Enamel, Ceramir CAD/CAM i-BLOCK (øL) A0, Ceramir CAD/CAM i-BLOCK (øL) A1, Ceramir CAD/CAM i-BLOCK (øL) A2 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crown, Preformed | ELZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| October 18, 2024 | K241131 | edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK | EBF | Substantially Equivalent | Edelweiss Dentistry Products GmbH | accessdata.fda.gov |
Compare with other makers
Updated October 18, 2024. 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.