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
Dental and craniomaxillofacial CBCT segmentation, measurement and visualization support
FDA source Exact FDA submission Checked 2026-09-05
Segmentations/labels for teeth, maxillofacial anatomy and restorations; manual/automated distance, area, angle and signal-intensity measures; MPR, 3D volume-rendering and PDF report.
FDA source Exact FDA submission Checked 2026-09-05
Diagnostic-support tool only; it does not replace complete clinician review or clinical judgment. It is limited to 3D CBCT and PDF output, not treatment-design export.
FDA source Exact FDA submission Checked 2026-09-05
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
K251514
FDA source Exact FDA submission Checked 2026-08-31
Public source Exact FDA submission Checked 2026-08-13
Preserved prior baseline category. FDA summary calls the subject a web application; exact purchased hosting/data-flow configuration needs confirmation.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
Pivotal retrospective study used 100 CBCT scans independently annotated by three US-licensed oral and maxillofacial radiologists/dentists across multiple scanner manufacturers. FDA reports pre-specified goals met; it does not establish patient outcomes.
FDA source Exact FDA submission Checked 2026-09-05
K251514 CBCT Assist pivotal retrospective performance study
Retrospective standalone segmentation and measurement accuracy study · Diverse CBCT scans from multiple manufacturers with three US-licensed oral/maxillofacial radiologist/dentist annotations
exact submission · Tested version: Overjet CBCT Assist v1 · n=100 · Independence not established
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-06
Official demo pages do not publish a CBCT Assist rate or procurement quote.
Reimbursement and coding
Research pending
Needs research Exact FDA submission Checked 2026-09-06
No applicable payer policy reviewed; vendor marketing statements about practice outcomes do not establish coverage.
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
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-04
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
Verify security and privacy controls: No scoped dated security attestation reviewed.
Verify training: Dental CBCT onboarding and local acceptance/training requirements require confirmation.
Verify pricing and total cost: Official demo pages do not publish a CBCT Assist rate or procurement quote.
Verify reimbursement and coding relevance: No applicable payer policy reviewed; vendor marketing statements about practice outcomes do not establish coverage.
Verify local validation and lifecycle monitoring: Post-deployment segmentation-error monitoring and update controls require confirmation.
Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-06Last searched
22Fields reviewed
10Source classes checked
0Reviewed PubMed leads
0Reviewed trial leads
0Unreviewed FDA recall leads
Stored PubMed and clinical-trial arrays are empty and were screened. The current discovery snapshot contains 0 PubMed and 0 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, fda decision summary, acr ai central product, vendor product page, literature index, trial registry, recall database, pubmed, clinical trials, openfda device recall
Relu Creator manages, transfers, displays, enhances, and analyzes dental and craniomaxillofacial image information and provides design input for dental solutions within the...