Data / Medical devices / France / Euroteknika
Euroteknika: FDA-registered device maker in SALLANCHES Haute-Savoie, France, 1 510(k) clearance
Euroteknika is registered with the FDA (registration 3007521935) in SALLANCHES Haute-Savoie, France. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 4, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007521935
- Address
- 726 rue du General de Gaulle, SALLANCHES Haute-Savoie, France, 74700
- Owner or operator
- EUROTEKNIKA (10030222)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- May 13, 2025
- Registered through
- 2026
- Brand names listed
- iPhysio System Profile Designer, iPhysio System Temporary Abutments, iPhysio System Try-in Abutments
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| March 4, 2025 | K232383 | iPhysio® System | NHA | Substantially Equivalent | Euroteknika | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Accessories, Implant, Dental, Endosseous
Updated March 4, 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.