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Premarket Notification Requirements for Dental Curing Light Devices (DRAFT)

This guidance applies to dental curing lights regulated under 21 CFR 872.6070 with product code EBZ (Activator, Ultraviolet, for Polymerization). It excludes laser devices for polymerization and devices exclusively for tooth whitening procedures.

This is a draft guidance. Not for implementation.

  1. Conduct comprehensive device characterization including radiant power output, heat generation, and depth of cure testing
  2. Perform electrical safety and EMC testing according to relevant standards
  3. Complete biocompatibility evaluation for patient-contacting materials
  4. Develop detailed labeling including all required specifications and safety information
  5. Prepare software documentation appropriate to device complexity
  6. Validate reprocessing procedures and instructions
  7. Assess cybersecurity requirements and implement necessary controls
  8. If wireless technology is used, conduct additional RF testing
  9. Document all testing results in appropriate format for 510(k) submission
  10. Ensure all modifications are properly evaluated for need of new 510(k)

Key Considerations

Non-clinical testing

  • Radiant power output testing according to ISO 10650
  • Heat generation testing under normal and fault conditions
  • Depth of cure testing on representative dental restorative resin
  • Electrical safety testing according to IEC 60601-1 and IEC 80601-2-60
  • EMC testing according to IEC 60601-1-2

Software

  • Basic documentation level typically required
  • Full description of software functions
  • Validation and verification documentation
  • Additional requirements for OTS software if applicable

Cybersecurity

  • Required documentation if device meets cyber device definition
  • Assessment of cybersecurity risks and mitigations

Labelling

  • Total radiant power output specifications
  • Maximum light intensity specifications
  • Peak wavelength information
  • Recommended distance and angle of use
  • Recommended curing times
  • Instructions for protective equipment use
  • Reprocessing instructions
  • Warnings about thermal hazards

Biocompatibility

  • Testing required for patient-contacting materials:
    • Cytotoxicity
    • Sensitization
    • Irritation/intracutaneous reactivity

Safety

  • Electrical safety testing
  • EMC testing
  • Heat generation safety limits
  • Protection against excessive radiation

Other considerations

  • ISO 10650: Dentistry – Powered Polymerization Activators
  • IEC 60601-1: Medical electrical equipment – General requirements for basic safety
  • IEC 80601-2-60: Medical electrical equipment - Particular requirements for dental equipment
  • IEC 60601-1-2: EMC requirements for medical electrical equipment
  • ISO 7405: Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
  • ISO 12609-1: Eyewear for protection against intense light sources
  • ISO 12609-2: Eyewear for protection - Guidance for use

Original guidance

  • Premarket Notification Requirements for Dental Curing Light Devices
  • HTML / PDF
  • Issue date: 2024-07-12
  • Last changed date: 2024-07-11
  • Status: DRAFT
  • Official FDA topics: Medical Devices, 510(k), Dental, Premarket
  • ReguVirta summary file ID: 03c9ee7e1500b69b1b356c21b8c17512
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