# K252538: CEPHX3D

- Pathway: 510(k) (Traditional)
- Applicant: Orca Dental AI, Ltd.
- Decided: Mar 5, 2026 after 205 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K954678 (1996). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233925: Relu Creator, Relu BV (2024) Summary page 7.

## Indications for use
CephX3D is a software program for the analysis of dental and craniomaxillofacial image information and can be used to provide design input for dental solutions. It processes and displays digital images from various sources to support the diagnostic process and treatment planning. It is intended for use in patients aged 12 and older.

Source page: https://510kreport.com/device/K252538
Methodology: https://510kreport.com/methodology