FDA-cleared profile
Pearl, Inc.
Authorized purpose: Aids dental professionals in detecting caries on digital bitewing and periapical radiographs from patients aged 4 years and older with primary, permanent, or mixed dentition; polygon overlays require clinical review.
Product overview
Authorized purpose: Aids dental professionals in detecting caries on digital bitewing and periapical radiographs from patients aged 4 years and older with primary, permanent, or mixed dentition; polygon overlays require clinical review.
Overview status: Source-reviewed overview
Clinical role: Aids dental professionals in detecting caries on digital bitewing and periapical radiographs from patients aged 4 years and older with primary, permanent, or mixed dentition; polygon overlays require clinical review.
Evidence from the reviewed source record: Study type: Stand-Alone Performance. Cases: 1182. Reported sensitivity: 87% (95% CI: 84%, 90%)
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact clinical-use normalization from the FDA packet; this text is also the locked corrections value.
Intended-user text reported in the exact-submission ACR model card.
Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.
Conservative normalization of explicit wording in an exact-submission source.
Conservative normalization of explicit wording in an exact-submission source.
Clinical output reported in the exact-submission ACR model card.
Exact-product limitations and clinician-review boundary from the FDA packet.
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.
Imaging modality reported in the exact-submission ACR AI Central model card.
Anatomy normalized from explicit exact-submission ACR model-card wording.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
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, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Pearl's help content describes bitewing and periapical finding categories and an age-4-or-older family clearance context for those views.
product family · checked 2026-09-06Exact K243893 behavior remains governed by its FDA labeling.
Evidence
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.
Structured study metadata from the exact-submission ACR model card; this is not an independent evidence synthesis.
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
This field has not been curated yet.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K243893
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
Official non-FDA product sources were reviewed for buyer and workflow context, but no exact-submission amount, currency, unit, term, or implementation fee was displayed. A vendor quote remains required.
Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
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
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
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, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: regulatoryIdentity, purpose, modality, anatomy
Scope: regulatoryIdentity, modalityContext
Scope: purpose, modality, intendedUsers, careSetting, output, reportedSensitivity, evidenceSummary, anatomy, evidenceStudies
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: recallDiscovery, nativeSubmissionMatching
Scope: identity, clinical, evidence, implementation
Scope: buyer_workflow, clinical, implementation
Scope: clinical, limitations, implementation
Regulatory record
510(k)
Research record
human reviewed
Editorial review
Source-reviewed editorial overlay
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