FDA-cleared profile

CEPHX3D

Orca Dental AI, Ltd.

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.

Quantification and segmentation

Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.

Clinical fit

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact 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.

Intended users: Qualified dentists, dental radiologists, oral and maxillofacial surgeons, and trained dental imaging staff.

Care setting and population: Dental, oral and maxillofacial, hospital, and surgical-planning environments.

Workflow role: Dental image visualization, segmentation, measurement, implant or trajectory planning, and three-dimensional model support.

Required input: Supported dental CT, cone-beam CT, panoramic, cephalometric, or related radiographic data.

Output and human action: Three-dimensional models, measurements, planning views, templates, and reports for professional review.

Limitations: Planning outputs do not replace clinical examination or professional judgment; image quality, scan protocol, anatomy, manufacturing, and age or indication limits apply.

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission: K252538

Modality: CBCT

Anatomy: Dental and craniomaxillofacial anatomy

Clearance type: 510(k)

Decision date: 2026-03-05

FDA status: FDA-cleared

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration: The exact FDA material describes image import, WebGL display, STL model output, and manual segmentation refinement; validate the installed import, export, identity, geometry, and planning workflow locally.

Deployment and data flow: Not established in reviewed sources

Security and privacy: Vendor documentation pending

Training and support: Only qualified dentists, dental radiologists, oral and maxillofacial surgeons, and trained dental imaging staff should operate or interpret the product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.

Monitoring and change control: Monitor by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: Planning outputs do not replace clinical examination or professional judgment; image quality, scan protocol, anatomy, manufacturing, and age or indication limits apply.

Release and scope verification

Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K252538 before acceptance.

exact submission · checked 2026-09-04

Later product-family features are not evidence that this cleared release includes them.

Source

Interoperability acceptance

The exact FDA material describes image import, WebGL display, STL model output, and manual segmentation refinement; validate the installed import, export, identity, geometry, and planning workflow locally.

product family · checked 2026-09-04

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. Current vendor material is product-family context; confirm exact release, enabled options, deployment, and local compatibility.

Source Source

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. Planning outputs do not replace clinical examination or professional judgment; image quality, scan protocol, anatomy, manufacturing, and age or indication limits apply.

exact submission · checked 2026-09-04

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-04

No exact-product price was found in the reviewed public material; productivity or value claims require local evidence.

Source

Lifecycle monitoring

Monitor by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: Planning outputs do not replace clinical examination or professional judgment; image quality, scan protocol, anatomy, manufacturing, and age or indication limits apply.

product family · checked 2026-09-04

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. Current vendor material is product-family context; confirm exact release, enabled options, deployment, and local compatibility.

Source Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.

Evidence summary: The exact FDA decision material describes digital-image processing, STL models, a WebGL viewer, manual segmentation refinement, linear, angular, and volumetric measurements, and professional review. Current platform or cloud statements are not treated as exact-release deployment evidence.

Reported sensitivity: Not applicable

Reported specificity: Not applicable

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

K252538 FDA evidence package for CEPHX3D

FDA software substantial-equivalence decision with image-processing, segmentation, measurement, model-rendering, and usability verification · Dental and craniomaxillofacial image studies for patients age 12 and older within the labeled planning workflow

exact submission · Tested version: CEPHX3D configuration described in K252538 · Sponsor or vendor study

K252538

Manufacturer evidence submitted for the exact FDA decision. It is not independent clinical validation, and local technical, clinical, privacy, security, and workflow acceptance remains necessary.

Source

Economics and lifecycle

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost: Not established in reviewed sources

Reimbursement and coding: No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging, procedural, or surgical service line and verify payer, site-of-service, and coding assumptions independently.

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Build a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.

Source

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review: The 2026-09-02 openFDA device-recall snapshot contained no record matched to K252538 by exact native submission identifier. This does not exclude product-family, later, or adverse-event information.

Buyer worksheet

Open questions to take to the vendor

Verify deployment and data flow: The public exact-submission material does not establish the complete deployment topology, hosting responsibility, availability, upgrade path, or service contract.
Verify security and privacy controls: Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
Verify pricing and total cost: No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus

2026-09-04Last searched

26Fields reviewed

10Source classes checked

0Unreviewed PubMed leads

0Unreviewed trial leads

0Unreviewed FDA recall leads

This submission was added after the prior exact-submission extraction and remains queued for source review. Exact-name and exact-submission searches in the checked 2026-09-01 indexes returned no PubMed records and no ClinicalTrials.gov records for K252538; review status is candidate_review_pending. Any candidate literature or registry record remains quarantined as product-family evidence unless exact submission and version linkage is established. Current vendor material is product-family context. Pricing, complete security architecture, contracted deployment, exact reimbursement, and local interoperability remain unverified. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision material, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

Sources

Source ledger

Sources accessed through 2026-09-04.

FDA 510(k) decision material K252538: CEPHX3D U.S. Food and Drug Administration · 2026-09-04
Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
Medicare Coverage Database Centers for Medicare & Medicaid Services · 2026-09-01
openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
CephX dental-imaging family CephX · 2026-09-04

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