FDA-cleared profile
DGNCT, LLC
Diagnocat is an automated concurrent-read aid for detecting periapical radiolucency on permanent teeth in previously acquired, clinically justified maxillofacial CBCT; it is a second-read aid and does not replace complete dental-professional review or judgment.
Clinical fit
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
The FDA decision material does not establish the complete security posture for the exact product and deployment. Obtain architecture, identity, audit, encryption, retention, support-access, vulnerability-management, and incident-response evidence.
Map the installed product, build, options, population, anatomy, inputs, outputs, and enabled functions to K252934 before acceptance.
exact submission · checked 2026-09-04Later product-family features are not evidence that this cleared release includes them.
The FDA package describes web and desktop application forms; current hosting, network, security, and local operational configuration remain unverified.
exact submission · checked 2026-09-04FDA-described deployment details do not establish current hosting contracts, security controls, uptime, or local qualification.
The FDA package describes DICOM CBCT input and web or desktop outputs; exact local routing, viewer, archive, and reporting interfaces require testing.
exact submission · checked 2026-09-04Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.
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. Diagnocat is a second-read aid and does not replace complete dental review or clinical judgment. The cleared population, permanent dentition, maxillofacial CBCT, clinically justified acquisition, and trained-user limits apply.
exact submission · checked 2026-09-04Define stop-use, escalation, rollback, and revalidation triggers before production use.
Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, infrastructure, training, service, downtime, upgrade, and replacement costs.
product family · checked 2026-09-04No exact-product price or product-specific reimbursement was established in the reviewed public material.
Monitor K252934 by exact software, hardware, 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: Diagnocat is a second-read aid and does not replace complete dental review or clinical judgment. The cleared population, permanent dentition, maxillofacial CBCT, clinically justified acquisition, and trained-user limits apply.
exact submission · checked 2026-09-04Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
FDA 510(k) verification and validation evidence described in the exact submission · Maxillofacial region; permanent teeth; periapical radiolucency
exact submission · Tested version: Diagnocat · Sponsor or vendor studyK252934
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.
Economics and lifecycle
These are common procurement questions; unknown values remain visible until a source supports them.
No public list price for the exact cleared product version was established. Obtain a written quote separating license, implementation, interfaces, compute, storage, training, support, upgrades, renewal, and exit costs.
No separate named-product payment identified in reviewed CMS material
Centers for Medicare & Medicaid Services · United StatesThis is not a product-specific reimbursement determination. Verify payer, site-of-service, coding, and coverage assumptions independently.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Screened 20 PubMed titles and one trial record. Some concern dental AI, CBCT, or periapical radiolucency, but none identifies Diagnocat, K252934, and the tested release; all 21 are quarantined. The current discovery snapshot contains 20 PubMed and 1 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, acr ai central product, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-04.
Alternatives
Dentsply Sirona
DS Core CBCT Anatomy uses CBCT and digital-impression data to provide tooth and jaw segmentation, inferior-alveolar-nerve-canal segmentation, panoramic-curve support, and...
Orca Dental AI, Ltd.
CEPHX3D processes dental and craniomaxillofacial images to support diagnosis and treatment planning, including three-dimensional models, viewing, segmentation, measurements, and...
Dentsply Sirona, Inc.
FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...
Overjet, Inc.
Dental and craniomaxillofacial CBCT segmentation, measurement and visualization support