# Infinitum Eta, Ltd.

- Location (FDA's records): Petach Tikva, IL
- FDA decisions: 3 (2024–2025): 3 510(k) clearances
- Product codes: KCT (1), NHA (1), DZE (1)
- 510(k) review time since 2016: median 112 days, against 205 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 7 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nobel Biocare AB: 3 (https://510kreport.com/company/nobel-biocare)
- Z-Systems AG: 1 (https://510kreport.com/company/z-systems)
- Institut Straumann AG: 1 (https://510kreport.com/company/institut-straumann)
- Nobel Biocare USA, LLC: 1 (https://510kreport.com/company/nobel-biocare-usa)
- Straumann USA: 1 (https://510kreport.com/company/straumann-usa)

## Recent decisions
- K251220: NUVENTUS NV.C™ Prosthetic Components (Jul 28, 2025)
- K243317: NUVENTUS NV.C™ Surgical Cassette and Tray (Feb 11, 2025)
- K233081: NUVENTUS NV.C™ Dental Implant System (Nov 15, 2024)

Source page: https://510kreport.com/company/infinitum-eta