Legal & Compliance

Regulatory Status

SMILE EDITOR — REGULATORY STATUS & INTENDED USE

GLOBAL DRAFT — MUST BE REVIEWED BY REGULATORY COUNSEL BEFORE PUBLICATION

This page describes the intended role of Smile Editor as currently designed. Regulatory classification, registration, clearance or approval may differ by jurisdiction and by feature.

1. Intended Use

Smile Editor is intended as a computer-aided design (CAD) and visualization aid for trained dental professionals to visualize, create, position, modify and export patient-specific dental restorative geometries based on digital dental models.

Current planned restorative workflows may include veneers and crowns/restorative designs on natural teeth, subject to the capabilities and regulatory status of the released version.

2. Intended Users

Smile Editor is intended for:

  • licensed dentists;
  • dental technicians/laboratories where legally permitted;
  • authorized members of a dental professional's team acting within their lawful scope.

It is not intended for unsupervised patient self-treatment.

3. Clinical Responsibility

Smile Editor is a design aid. Unless a feature is specifically authorized and labeled otherwise, it:

  • does not diagnose disease;
  • does not independently prescribe treatment;
  • does not replace clinical examination;
  • does not determine whether a restoration is clinically indicated;
  • does not autonomously approve a design for patient use.

The treating professional is responsible for clinical assessment and final validation.

4. Manufacturing

Smile Editor may export digital geometry for downstream manufacturing. Manufacturing suitability depends on the selected printer/mill, material, calibration, software, post-processing and validated workflow.

The user is responsible for using legally marketed/appropriate materials and equipment and validating the manufactured result before clinical use.

5. Feature-Specific Regulatory Boundaries

Different features may have different regulatory status. Features for visualization, manual CAD, AI analysis, diagnosis, implant planning, automated treatment recommendation or other functions must not be assumed to share the same regulatory classification.

A feature labeled "Research", "Demo", "Preview", "Beta" or "Non-clinical use only" must not be used beyond that limitation.

6. Regional Status

Do not claim FDA clearance/approval, ANVISA registration, CE marking, UKCA marking or equivalent status unless the specific product/version and intended use have actually obtained the applicable status.

Before commercial launch in each regulated market, Smile Editor should complete a documented regulatory assessment covering at least:

  • Brazil / ANVISA;
  • United States / FDA;
  • European Union / MDR;
  • United Kingdom / UK medical-device rules;
  • other target jurisdictions.

7. Reporting Product Problems

Suspected malfunctions, quality issues or adverse events should be reported to [SUPPORT/REGULATORY EMAIL].

Reporting to Smile Editor does not replace any reporting obligation the clinician or facility may have to a regulator.

8. Software Identification

Production versions should display:

  • product name;
  • version/build;
  • manufacturer/legal entity;
  • regulatory identifiers where applicable.

9. Changes

This page must be updated when product functionality, intended use or regulatory status changes.