Data / Medical devices / Israel / Orca Dental Ai
Orca Dental Ai: FDA-registered device maker in Ra'anana Central, Israel, 2 510(k) clearances
Orca Dental Ai is registered with the FDA (registration 3030655434) in Ra'anana Central, Israel. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 5, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030655434
- Address
- 5, Hatidhar, Ra'anana Central, Israel, 4366507
- Owner or operator
- Orca Dental AI (10090134)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 5, 2024
- Registered through
- 2026
- Brand names listed
- CEPHX, CEPHX- Cephalometric Analysis Software, CEPHX3D
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 5, 2026 | K252538 | CEPHX3D | QIH | Substantially Equivalent | Orca Dental AI , Ltd. | accessdata.fda.gov |
| January 31, 2024 | K231396 | CEPHX- Cephalometric Analysis Software | LLZ | Substantially Equivalent | Orca Dental AI , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of System, Image Processing, Radiological
Updated March 5, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.