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Dental Curing Lights - Performance Testing and Safety Requirements

This guidance applies to dental curing lights used for photoactivation of resins and dental bleaching agents (class II devices) that use light sources such as quartz-tungsten-halogen lamps, LEDs, xenon-plasma arcs, and lasers. It excludes heat or light sources intended exclusively for tooth bleaching procedures.

  1. Conduct performance testing according to ANSI/ADA Specification No. 48
  2. Perform electrical safety and EMC testing
  3. Develop and validate infection control procedures
  4. Create comprehensive device labeling including all required elements
  5. Prepare detailed comparison to predicate devices
  6. Validate thermal and optical radiation safety
  7. If software-controlled, ensure software documentation meets requirements
  8. Document all testing results and validation data for 510(k) submission
  9. Develop clear reprocessing instructions for end users
  10. Ensure compliance with laser requirements if applicable

Key Considerations

Non-clinical testing

  • Evaluate irradiance at 2mm from light guide showing maximum light intensity (mW/cm2)
  • Provide spectral irradiance plot showing peak wavelength (nm)
  • Demonstrate depth of cure on representative resin sample
  • Validate that device does not present thermal hazard during longest prescribed curing times
  • Validate that optical radiation emissions do not present hazards during maximum exposure times

Software

  • Follow FDA guidance for software contained in medical devices if device is software-controlled
  • Follow general principles of software validation

Labelling

  • Include maximum light intensity
  • Include peak wavelength
  • List compatible curing systems
  • Include warnings about optical radiation and thermal hazards
  • Provide detailed reprocessing instructions (disassembly, cleaning, disinfection/sterilization, etc.)
  • Comply with laser labeling requirements if applicable (21 CFR 1040.10(g))

Safety

  • Demonstrate electrical safety compliance
  • Demonstrate electromagnetic compatibility (EMC)
  • Validate infection control procedures including disinfection/sterilization parameters
  • Validate that patient-contacting portions do not present thermal hazards

Other considerations

  • ANSI/ADA Specification No. 48: Visible Light Curing Units, 2004
  • IEC 60601-1:1988: Medical Electrical Equipment – Part 1: General requirements for safety
  • IEC 60601-1-2:1993: Medical Electrical Equipment – Part 1: General requirements for safety – 2. Collateral Standard: Electromagnetic compatibility

Original guidance

  • Dental Curing Lights - Performance Testing and Safety Requirements
  • HTML / PDF
  • Issue date: 2006-03-27
  • Last changed date: 2020-03-19
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Dental, Premarket
  • ReguVirta summary file ID: fc2618026160065c57f4d26456e117aa
This post is licensed under CC BY 4.0 by the author.