Data / Medical devices / Switzerland / Infinetamed AG
Infinetamed AG: FDA-registered device maker in Sarnen Obwalden, Switzerland, 3 510(k) clearances
Infinetamed AG is registered with the FDA (registration 3038549074) in Sarnen Obwalden, Switzerland. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 28, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038549074
- Address
- Kagiswilerstrasse 17, Sarnen Obwalden, Switzerland, 6060
- Owner or operator
- InfinetaMed AG (10093879)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- July 27, 2025
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| July 28, 2025 | K251220 | NUVENTUS NV.C Prosthetic Components | NHA | Substantially Equivalent | Infinitum Eta, Ltd. | accessdata.fda.gov |
| February 11, 2025 | K243317 | NUVENTUS NV.C Surgical Cassette and Tray | KCT | Substantially Equivalent | Infinitum Eta, Ltd. | accessdata.fda.gov |
| November 15, 2024 | K233081 | NUVENTUS NV.C Dental Implant System | DZE | Substantially Equivalent | Infinitum Eta, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Implant, Endosseous, Root-Form
- All makers of Accessories, Implant, Dental, Endosseous
Updated July 28, 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.