# Fona S.R.L

- Location (FDA's records): Assago, IT
- FDA decisions: 4 (2016–2022): 4 510(k) clearances
- Product codes: MUH (2), EHD (1), OAS (1)
- 510(k) review time since 2016: median 84 days, against 69 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 5 (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
- Blue X Imaging Srl: 2 (https://510kreport.com/company/blue-x-imaging)
- Sirona Dental Systems GmbH: 2 (https://510kreport.com/company/sirona-dental-systems)
- Denterprise International, Inc.: 1 (https://510kreport.com/company/denterprise-international)

## Recent decisions
- K222274: Fona XDC (Aug 23, 2022)
- K213579: Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph (Mar 2, 2022)
- K212103: StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 (Aug 30, 2021)
- K161131: FONA Pan/Ceph (Nov 3, 2016)

Source page: https://510kreport.com/company/fona