Regulatory & Compliance
MEDICAL DEVICE INFORMATION
Product Name:
CEPHX – Cephalometric Analysis Software
Product Code:
QIH
Software version:
4.02
Manufacturer:
Orca Dental AI Ltd.
Date of Manufacturing:
21/Apr/2024
MEDICAL DEVICE INFORMATION
Product Name:
CEPHX3D
Product Code:
QIH
Software version:
1.01
Manufacturer:
Orca Dental AI Ltd.
Date of Manufacturing:
24/Jan/2026
Support
E-mail:
Terms and conditions pertaining to the use of the CEPHX software can be found at: https://cephx.com/terms-of-service/
Software Distribution: This device is distributed in the United States of America (USA) and Canada.
Support
E-mail:
Terms and conditions pertaining to the use of the CEPHX3D software can be found at: https://cephx.com/terms-of-service/
Software Distribution: This device is distributed in the United States of America (USA).
MEDICAL DEVICE INFORMATION
Product Name:
CEPHX EU
Software version:
1.00
Actor ID/SRN :
IL-MF-000056113
Manufacturer:
Orca Dental AI
Date of Manufacturing:
11/Jun/2026
Support
E-mail:
Terms and conditions pertaining to the use of the CEPHX software can be found at: https://cephx.com/terms-of-service/
UDI-DI code: 07290019703020
Software Distribution: This device is distributed in the European Union (EU).