# Orca Dental AI, Ltd.

- Location (FDA's records): Herzliya, IL
- FDA decisions: 2 (2024–2026): 2 510(k) clearances
- Product codes: LLZ (1), QIH (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 1 (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
- Assemblecircle Corp.: 1 (https://510kreport.com/company/assemblecircle)
- Relu BV: 1 (https://510kreport.com/company/relu)

## Firms that cite its devices most
- Audax D.O.O.: 1 (https://510kreport.com/company/audax-doo)

## Its most-cited devices
- K231396: CEPHX- Cephalometric Analysis Software (2024), cited by 1

## Recent decisions
- K252538: CEPHX3D (Mar 5, 2026)
- K231396: CEPHX- Cephalometric Analysis Software (Jan 31, 2024)

Source page: https://510kreport.com/company/orca-dental-ai