Regulatory & Compliance

HIPAA FDA 510(k) Cleared Health Canada GDPR PIPEDA CE Mark

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

Support

E-mail:
support@cephx.com

Terms and conditions pertaining to the use of the CEPHX software can be found at: https://cephx.com/terms-of-service/

CephX UDI Barcode

Software Distribution: This device is distributed in the United States of America (USA) and Canada.

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:
support@cephx.com

Terms and conditions pertaining to the use of the CEPHX3D software can be found at: https://cephx.com/terms-of-service/

CEPHX 3D UDI Barcode

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:
info@cephx.com

Terms and conditions pertaining to the use of the CEPHX software can be found at: https://cephx.com/terms-of-service/

CEPHX EU

UDI-DI code: 07290019703020

Software Distribution: This device is distributed in the European Union (EU).

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