Manufacturer registered with FDA
Infinitum Eta Ltd.
Petach Tikva, Israel. Lists 3 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 0
- 510(k) clearances
- 22024–2025
- Markets registered in
- 1United States
- Establishments
- 1Israel
510(k) clearances per year, 2007–2026
Devices listed with FDA
What Infinitum Eta Ltd. 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
510(k) clearances
Clearances on which FDA names Infinitum Eta Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 28 Jul 2025 | K251220 | NUVENTUS NV.C Prosthetic Components | NHA Endosseous Dental Implant Abutment |
| 15 Nov 2024 | K233081 | NUVENTUS NV.C Dental Implant System | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: InfinetaMed AG (2).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| INFINITUM ETA LTD.FDA reg. 3027665899 | Petach Tikva Central, Israel | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10092579). 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.