Turn this list into an evaluation

Each entry is an FDA submission, not a distinct commercial offer. Inspect the exact record before comparing evidence, asking for a quote or planning an integration.

Prepare with a buyer guide:

Clinical guide links appear when this list contains a current reviewed example. They do not classify or endorse the other entries. All buyer guides · Compare exact records · Documented families

FDA-cleared K252538

CEPHX3D

Orca Dental AI, Ltd.

Authorized purpose: CEPHX3D processes dental and craniomaxillofacial images to support diagnosis and treatment planning, including three-dimensional models, viewing, segmentation, measurements, and dental-solution design input for patients age 12 and older.

Modality
CBCT
Anatomy
Dental and craniomaxillofacial anatomy
Decision
2026-03-05
FDA-cleared K231396

CEPHX- Cephalometric Analysis Software

Orca Dental AI LTD

Authorized purpose: Cephalometric image analysis, simulation, visual treatment objective support, and consultation for dental and orthodontic professionals treating patients aged 14 years and older.

Modality
X-ray/Radiography
Anatomy
Head/Neck
Decision
2024-01-31