Data / Medical devices / Austria / EC Certification Service GmbH
EC Certification Service GmbH: FDA-registered device maker in St. Veit/Glan Karnten, Austria, 1 510(k) clearance
EC Certification Service GmbH is registered with the FDA (registration 3008796797) in St. Veit/Glan Karnten, Austria. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 21, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008796797
- Address
- Sandgasse 39a, St. Veit/Glan Karnten, Austria, 9300
- Owner or operator
- EC Certification Service GmbH (10035465)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- December 30, 2022
- Registered through
- 2026
- Brand names listed
- Clear, Clear Plus, ECC Premium Line, Larson Radius, Metal Triple Edge Button, Ring Button, Shark 80, Shark SL and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bracket, Metal, Orthodontic | EJF | 1 | Manufacturer | accessdata.fda.gov |
| Bracket, Plastic, Orthodontic | DYW | 2 | Manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | 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 |
|---|---|---|---|---|---|---|
| April 21, 2025 | K251196 | Composite Orthodontic Brackets and Buttons | DYW | Substantially Equivalent | Ec Certification Service GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Wire, Orthodontic
- All makers of Bracket, Plastic, Orthodontic
- All makers of Bracket, Metal, Orthodontic
Updated April 21, 2025. 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.