Orca Dental AI, Ltd.
Active in EUDAMEDIsraelfrom SRN EUDAMED SRN IL-MF-000056113
- Devices
- 5
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What Orca Dental AI, Ltd. makes
Orca Dental AI, Ltd. makes software for dental analysis, including cephalometric analysis tools such as CEPHX- Cephalometric Analysis Software and CEPHX3D. These products are used in the field of dentistry for analytical purposes. The company's devices are related to dental imaging and analysis.
The company's portfolio is regulated as Class II devices and is listed in the FDA 510(k) registry. The devices are subject to regulatory oversight in the US, where the company is based. The regulatory classification and listing indicate the level of control and scrutiny applied to the devices.
Catalogue
CephX EU Ref ORC-03
Regimes: CE MDR Registry: EUDAMED- Registry: GUDID
- Registry: GUDID
CEPHX- Cephalometric Analysis Software Ref K231396
Regimes: 510(k) Registry: 510(k)CEPHX3D Ref K252538
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- IL-MF-000056113
- DUNS number
- 514417294
- EU VAT number
- 511554818
- EUDAMED status
- Active
- EUDAMED registered name
- Orca Dental AI
- Registered address
- 5, Hatidhar, 4366507, Ra'anana, Israel
- Website
- cephx.com/homepage-eu/
- [email protected]
- Phone
- +972538789977
- PRRC contact
- Moshe Melamed
Frequently asked questions
How many devices does Orca Dental AI, Ltd. have in the registry?
The registry currently lists 5 devices for Orca Dental AI, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orca Dental AI, Ltd.'s devices?
Among its 5 most recently registered devices, Orca Dental AI, Ltd. has devices listed in EUDAMED (1 device), FDA 510(k) (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Orca Dental AI, Ltd.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Orca Dental AI, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orca Dental AI, Ltd. in the registry?
The most recently registered devices listed for Orca Dental AI, Ltd. include CephX EU, CEPHX- CEPHALOMETRIC ANALYSIS SOFTWARE 4.2, CEPHX3D 1.00 and CEPHX- Cephalometric Analysis Software.