Legal - Regulatory (United States)

Regulatory Position

Last updated: 2026-04-27 - v2.0

Current regulatory positionEarly-access workflow platform with controlled AI evaluation features

Cavitech is currently offered as an early-access dental workflow platform. Certain AI image-analysis modules are made available only as controlled investigational evaluation features and are not sold, marketed, or intended as cleared diagnostic medical-device functionality.

Cavitech does not currently claim FDA clearance, FDA approval, UKCA marking, CE marking under EU MDR, SAHPRA registration, or equivalent authorisation for diagnostic AI radiograph-analysis use.

This page explains Cavitech's current regulatory position and separates early-access workflow functionality from controlled investigational AI image-analysis evaluation features. Deployment, clinical evaluation, market availability, and product claims are subject to ongoing review with regulatory counsel and applicable regulators.

Current regulatory position

Cavitech is currently offered as an early-access dental workflow platform. The commercial subscription relates to workflow, viewer, documentation, reporting, case-management, collaboration, and administrative functionality.

Certain AI image-analysis modules, including radiograph AI and other clinical AI outputs, are currently investigational evaluation features. They are not FDA-cleared, UKCA marked, CE marked under EU MDR, SAHPRA-registered, or otherwise approved as diagnostic medical-device functionality.

AI outputs are candidate observations only. They must be independently reviewed, accepted, rejected, or edited by a qualified dental professional. Cavitech does not diagnose, prescribe, treat, replace clinical judgment, or act as the final decision-maker.

Commercial platform vs investigational AI modules

Feature category	Current status	Permitted use
Workflow platform	Commercial early access	Case management, imaging workflow, reporting templates, documentation, collaboration, administrative support, and related non-diagnostic workflow functions.
Image viewer and reporting tools	Commercial early access	Clinician-controlled image review, manual documentation, structured reporting, and record keeping.
AI radiograph-analysis candidate observations	Investigational evaluation feature	Clinician testing, review, feedback, validation, and evaluation only. Not for standalone diagnosis, treatment planning, referral decisions, prescribing, insurance claims, or patient-facing diagnostic conclusions.
Final diagnosis and treatment decisions	Clinician-controlled	The treating dentist or qualified clinician remains solely responsible for diagnosis, treatment planning, clinical decisions, patient communication, and record sign-off.

AI radiograph-analysis module

Cavitech's AI radiograph-analysis features are not sold or marketed as cleared diagnostic functionality. Access may be provided to selected qualified clinicians as part of a controlled early-access evaluation programme while regulatory clearance, validation, and conformity-assessment work is ongoing.

The AI outputs are candidate observations only. They may highlight possible areas or patterns for clinician review, but they do not constitute diagnoses, confirmed findings, treatment recommendations, or clinical instructions.

The treating clinician must independently review the original image, the relevant region of interest, any displayed AI overlay or confidence information, and the patient's full clinical context before making any clinical decision.

Not for standalone clinical use

AI outputs must not be used as the sole basis for diagnosis, treatment planning, referral, prescribing, insurance claims, patient communication, or any other clinical decision.

Cavitech does not replace the clinical judgment, responsibility, or professional duties of the dentist or qualified healthcare professional.

Independent clinician review

Cavitech is designed to support independent clinician review. Where AI candidate observations are displayed, the product should show the underlying image, relevant region of interest, overlay or marker, confidence information where available, and contextual information that helps the clinician understand why an area was highlighted.

Cavitech does not require, encourage, or permit clinicians to rely primarily on AI output. Every AI candidate observation must remain subject to manual clinician review, acceptance, rejection, or editing.

Controlled access evaluation programme

Investigational AI modules are available only to selected qualified dental professionals who accept Cavitech's Early Access Evaluation Terms.

Access may be limited, monitored, suspended, modified, or withdrawn as validation, safety monitoring, product development, or regulatory requirements evolve.

Participation in early access does not mean that Cavitech's AI modules are cleared, approved, certified, registered, or authorised for routine diagnostic use.

Subscription and investigational AI access

Subscription fees relate to Cavitech's workflow, documentation, case-management, collaboration, viewer, reporting, and platform functionality.

No separate diagnostic fee is charged for investigational AI radiograph-analysis access during the evaluation period.

Investigational AI access is provided for clinician evaluation, feedback, validation, and product-development purposes only. It is not sold, promoted, or represented as cleared diagnostic medical-device functionality.

User responsibilities

Users must:

Be qualified dental professionals or authorised clinical users.
Independently review all AI candidate observations.
Review the original image and relevant clinical context before making decisions.
Accept, reject, or edit AI candidate observations before including anything in a clinical record.
Not rely on Cavitech as the sole basis for diagnosis, treatment, referral, prescribing, insurance claims, or patient communication.
Not represent Cavitech AI outputs as cleared, approved, certified, registered, confirmed, or definitive diagnostic conclusions.
Use the platform only in accordance with applicable laws, professional obligations, data-protection requirements, and Cavitech's Early Access Evaluation Terms.

Patient-facing and third-party use

Users must not present Cavitech AI candidate observations to patients, insurers, regulators, employers, or other third parties as Cavitech-confirmed diagnoses, cleared findings, approved outputs, or automated diagnostic conclusions.

Any patient-facing communication, insurance submission, clinical record, referral letter, or treatment plan must be reviewed, controlled, and signed off by the treating clinician.

Validation and safety monitoring

Cavitech's validation programme may include dataset curation, annotation review, clinician feedback, sensitivity and specificity analysis, false-positive and false-negative review, model-version tracking, audit logs, performance monitoring, bias and subgroup analysis where applicable, and post-deployment feedback capture.

AI outputs, clinician actions, accept/reject decisions, edits, model versions, timestamps, and related usage data may be logged to support safety monitoring, performance evaluation, quality management, and future regulatory submissions, subject to applicable privacy, confidentiality, and data-protection requirements.

Jurisdiction availability

Region	Current status	Cavitech position
United States	Not FDA-cleared for diagnostic use.	Cavitech may offer commercial workflow/platform functionality. AI image-analysis modules remain investigational evaluation features and are not for routine clinical diagnosis unless and until applicable FDA requirements are satisfied.
United Kingdom	Not UKCA marked for diagnostic use.	Cavitech may offer non-diagnostic workflow/platform functionality. AI image-analysis modules are controlled evaluation features unless and until applicable UK medical-device, MHRA, UKCA, and clinical-investigation requirements are satisfied.
European Union	Not CE marked under EU MDR for diagnostic use.	Cavitech may offer non-diagnostic workflow/platform functionality. AI image-analysis modules are controlled evaluation features unless and until applicable EU MDR, CE marking, conformity-assessment, and clinical-evaluation requirements are satisfied.
South Africa	Not represented as SAHPRA-cleared, SAHPRA-registered, or SAHPRA-approved for diagnostic use.	Cavitech may offer workflow/platform functionality subject to applicable South African requirements. AI image-analysis modules are controlled evaluation features unless and until applicable SAHPRA, HPCSA, POPIA, establishment-licensing, and medical-device requirements are satisfied.

Jurisdiction detail

United States - FDA

U.S. Food and Drug Administration (FDA)

Cavitech is not FDA-cleared or FDA-approved for diagnostic use.
AI radiograph-analysis modules are investigational evaluation features.
Cavitech does not claim FDA approval, FDA clearance, safety, effectiveness, or diagnostic equivalence.
Cavitech does not promote the investigational AI module as a cleared diagnostic product.
Any future US diagnostic claims will require appropriate FDA pathway assessment, which may include 510(k), De Novo, or another applicable pathway depending on intended use, risk classification, predicate strategy, and FDA feedback.
Controlled evaluation access may be available where permitted and where appropriate regulatory, ethics, consent, monitoring, labelling, and documentation requirements are satisfied.

United Kingdom - MHRA / UKCA

Medicines and Healthcare products Regulatory Agency (MHRA) / UKCA

Cavitech is not currently UKCA marked for diagnostic AI radiograph-analysis use.
AI radiograph-analysis modules are not represented as authorised for routine diagnostic use in Great Britain.
Workflow and non-diagnostic features may be provided separately from investigational AI functions.
Any future UK diagnostic medical-device claims may require MHRA registration, UKCA or CE recognition as applicable, clinical evaluation, technical documentation, quality-management controls, post-market surveillance, and any required clinical-investigation steps.
Controlled evaluation access must not be represented as market authorisation.

European Union - EU MDR / CE

EU MDR / CE marking through an applicable Notified Body

Cavitech is not currently CE marked under the EU MDR for diagnostic AI radiograph-analysis use.
AI radiograph-analysis modules are not represented as authorised for routine diagnostic use in the EU.
Workflow and non-diagnostic features may be provided separately from investigational AI functions.
Future diagnostic medical-device claims may require MDR classification, conformity assessment, technical documentation, clinical evaluation, quality-management system, post-market surveillance, and CE marking before routine commercial diagnostic use.
AI-specific obligations may also apply depending on the final intended use and regulatory classification.

South Africa - SAHPRA / HPCSA / POPIA

SAHPRA / HPCSA / POPIA

Cavitech is not represented as SAHPRA-approved, SAHPRA-cleared, or SAHPRA-registered for diagnostic AI radiograph-analysis use.
Workflow and non-diagnostic platform features may be provided separately from investigational AI functions.
AI radiograph-analysis modules are controlled evaluation features and are not for standalone diagnosis or treatment decisions.
Cavitech will assess and comply with applicable SAHPRA medical-device establishment licensing, medical-device classification, clinical-investigation, import/export/manufacture/distribution/sale requirements, HPCSA professional obligations, and POPIA requirements.
Cavitech will assess applicable SAHPRA requirements as product configuration, intended use, distribution model, and classification evolve.

Early Access Evaluation Terms

The Early Access Evaluation Terms should address qualified clinician access only, investigational AI acknowledgement, no standalone clinical use, no patient-facing AI diagnostic claims, no insurance/claim submission based solely on AI output, independent clinical review, feedback and validation data usage, audit logging, model-version tracking, data-protection terms, the right to suspend/modify AI access, and no guarantee of clearance, approval, certification, registration, performance, availability, or future functionality.

View Early Access Evaluation Terms

Required AI-module acknowledgement

Before accessing investigational AI radiograph-analysis features, users must acknowledge that:

I understand Cavitech AI radiograph outputs are investigational.
I understand Cavitech is not FDA-cleared, UKCA marked, CE marked, or SAHPRA-registered for diagnostic AI radiograph-analysis use.
I understand AI outputs are candidate observations only.
I will independently review the original image, region of interest, and patient context.
I will not use AI outputs as the sole basis for diagnosis, treatment planning, referral, prescribing, insurance claims, or patient communication.
I will manually accept, reject, or edit any AI candidate observation before including it in a clinical record.
I will not represent Cavitech AI outputs as cleared, approved, certified, registered, confirmed, or definitive diagnostic conclusions.

Terminology

Avoided term	Preferred term
AI diagnosis	AI-assisted candidate observations
Detects pathology	May highlight candidate radiographic observations for clinician review
Second opinion	Review-support layer or clinician-assistive review support
Confirmed finding	Candidate observation pending clinician review
Approved soon / Soon to be approved	Regulatory clearance and conformity-assessment work is ongoing
Commercial distribution permitted under investigational use	Controlled evaluation access may be available where permitted and where applicable requirements are satisfied

Cavitech is an early-access dental workflow platform. Certain AI image-analysis modules are investigational evaluation features only. Cavitech does not currently claim FDA clearance, FDA approval, UKCA marking, CE marking under EU MDR, SAHPRA registration, or equivalent authorisation for diagnostic AI radiograph-analysis use. AI outputs are candidate observations only and must be independently reviewed by a qualified clinician. Cavitech does not diagnose, treat, prescribe, replace professional judgment, or act as the final clinical decision-maker.

Regulatory correspondence

This website content is not a substitute for legal or regulatory advice. Deployment, clinical evaluation, market availability, and claims remain subject to ongoing review with regulatory counsel and applicable regulators. Email regulatory@cavitech.ai.

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