Manufacturer registered with FDA
InfinetaMed AG
Sarnen, Switzerland. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 440 registrations outside the US
- Establishments
- 1Switzerland
Registered in 4 markets
Where regulators' registries name InfinetaMed AG as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | InfinetaMed AG | 3 device types | — | Below |
| Canada | Health Canada | Registration holder | INFINETAMED AG | 27 | 2025–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | InfinetaMed AG | 11 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | InfinetaMed AG | 2 | 2026–2026 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What InfinetaMed AG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | — | 2025 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | — | 2025 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | — | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
InfinetaMed AG lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Infinitum Eta Ltd. (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 28 Jul 2025 | K251220 | NUVENTUS NV.C Prosthetic Components | Infinitum Eta Ltd. | NHA Endosseous Dental Implant Abutment |
| 15 Nov 2024 | K233081 | NUVENTUS NV.C Dental Implant System | Infinitum Eta Ltd. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| INFINETAMED AGFDA reg. 3038549074 | Sarnen Obwalden, Switzerland | Complaint file establishment, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10093879). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.