Authorized purpose: Provides automated concurrent-read detection and segmentation of caries on bitewing radiographs in patients 18 and older, adding information for the dentist while requiring complete dentist review and judgment.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Provides automated concurrent-read detection and segmentation of caries on bitewing radiographs in patients 18 and older, adding information for the dentist while requiring complete dentist review and judgment.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: Provides automated concurrent-read detection and segmentation of caries on bitewing radiographs in patients 18 and older, adding information for the dentist while requiring complete dentist review and judgment.
Which images or clinical context are in scope?Modality: X-ray/Radiography Anatomy or clinical context: Dental/Maxillofacial Input: XRAY images or data. Inclusion criteria: Digital bitewing radiographic images of patients 18 years and older; minimum image resolution of 300 pixels; screen captures of bitewing radiographs
Who uses it?Intended users: Dentists
What does the software produce?Output: The AI model performs semantic segmentation on bitewing radiographs, assigning a probability value to each pixel for the possibility that it contains decay. A threshold is applied to determine which pixels are labeled in the output. The device outputs labeled regions indicating areas suspected of caries (decay) to aid the dentist in diagnosis.
What is its most important limitation?Key limitation: The device is not a replacement for dentist review or judgment; the FDA routine-use description of local processing does not establish every current commercial host, export, or enterprise deployment configuration.
Clinical takeaway
Clinical role: Provides automated concurrent-read detection and segmentation of caries on bitewing radiographs in patients 18 and older, adding information for the dentist while requiring complete dentist review and judgment.
Evidence takeaway
Evidence from the reviewed source record: Study type: Both. Cases: 400. Reported sensitivity: 68.6% (95% CI: 65.5%, 71.7%). Reader-study cases: 300. Readers: 12. Reader-study sensitivity: 67.4% (95% CI: 61.5%, 72.8%)
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
Provides automated concurrent-read detection and segmentation of caries on bitewing radiographs in patients 18 and older, adding information for the dentist while requiring complete dentist review and judgment.
FDA source
Exact FDA submission
Checked 2026-09-06
Exact clinical-use normalization from the FDA packet; this text is also the locked corrections value.
XRAY images or data. Inclusion criteria: Digital bitewing radiographic images of patients 18 years and older; minimum image resolution of 300 pixels; screen captures of bitewing radiographs
Public source
Exact FDA submission
Checked 2026-09-01
Conservative normalization of explicit wording in an exact-submission source.
The AI model performs semantic segmentation on bitewing radiographs, assigning a probability value to each pixel for the possibility that it contains decay. A threshold is applied to determine which pixels are labeled in the output. The device outputs labeled regions indicating areas suspected of caries (decay) to aid the dentist in diagnosis.
Public source
Exact FDA submission
Checked 2026-09-01
Clinical output reported in the exact-submission ACR model card.
The device is not a replacement for dentist review or judgment; the FDA routine-use description of local processing does not establish every current commercial host, export, or enterprise deployment configuration.
FDA source
Exact FDA submission
Checked 2026-09-06
Exact-product limitations and clinician-review boundary from the FDA packet.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
Public source
Exact FDA submission
Checked 2026-08-13
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
Training and support
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-08-13
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Monitoring and change control
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-08-13
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Family desktop workflow
The vendor says Sugarbot Detect runs on the desktop, works with existing imaging software without an integration, and can be installed in less than 15 minutes.
product family · checked 2026-09-07
Vendor product page; verify exact commercial mapping to SugarBug (1.x).
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
$99/month per office; the official page says unlimited AI analysis on up to five computers and offline use after activation on supported Windows systems. This is the Sugarbot Detect family offer; exact commercial mapping to FDA SugarBug (1.x) requires confirmation.
Vendor supplied
Product family
Checked 2026-09-07
Narrative vendor offer retained without normalizing the dollar symbol into a structured currency field.
Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
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: FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Verify reimbursement and coding relevance: Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
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
2026-09-07Last searched
26Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
Stored exact-submission candidate metadata had zero PubMed and ClinicalTrials.gov identifiers; this metadata screening is not a full paper or registry-record review. 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, vendor pricing observation, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history9 sources - 3 history items
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