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.
What You Need to Know? 👇
What are the key performance specifications required for dental curing light 510(k) submissions?
FDA recommends following ANSI/ADA Specification No. 48 and documenting irradiance at 2mm distance, spectral irradiance plot, light source type, power source, curing modes, safety controls, and depth of cure on representative resin samples.
Which product code and regulation apply to dental curing lights for photoactivation?
Dental curing lights fall under 21 CFR 872.6070 (Ultraviolet Activator for Polymerization) with product code EBZ, classified as Class II devices requiring 510(k) premarket notification before marketing.
What electrical safety standards must dental curing lights meet for FDA clearance?
FDA recommends demonstrating electrical safety compliance with ANSI/ADA Specification No. 48 (2004) and IEC 60601-1:1988 for medical electrical equipment general safety requirements, or equivalent methods.
How should manufacturers address infection control for dental curing light patient-contacting components?
Manufacturers must describe validated disinfection/sterilization parameters including suitable chemical disinfectants, cycle variables (time, temperature, pressure), and provide detailed reprocessing instructions following FDA guidance for reusable medical devices.
What thermal and optical safety considerations are required for dental curing lights?
Manufacturers must demonstrate that patient-contacting portions don’t present thermal hazards during longest prescribed curing times, and that optical radiation emissions don’t create hazards during maximum expected exposure times.
Can an Abbreviated 510(k) be used for dental curing light submissions?
Yes, FDA believes Abbreviated 510(k) provides the least burdensome approach for dental curing lights, especially with this guidance document available. It requires a summary report describing device development, testing methods, and risk mitigation.
What You Need to Do 👇
Recommended Actions
- Conduct performance testing according to ANSI/ADA Specification No. 48
- Perform electrical safety and EMC testing
- Develop and validate infection control procedures
- Create comprehensive device labeling including all required elements
- Prepare detailed comparison to predicate devices
- Validate thermal and optical radiation safety
- If software-controlled, ensure software documentation meets requirements
- Document all testing results and validation data for 510(k) submission
- Develop clear reprocessing instructions for end users
- 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
- Describe principles of operation
- Provide comparison to predicate devices
- Include device design details (operational modes, light source, power source)
- Specify material composition of patient-contacting portions
Relevant Guidances 🔗
- Premarket Notification Requirements for Dental Curing Light Devices (Draft)
- Content of Premarket Submissions for Device Software Functions
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
Related references and norms 📂
- 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