Premarket Notification Requirements for Dental Composite Resin Materials
This guidance covers dental composite resin devices classified under 21 CFR 872.3690 (Tooth Shade Resin Material) and 21 CFR 872.3765 (Pit and Fissure Sealant and Conditioner). These devices are intended to fill and restore small to large defects or carious lesions in teeth, available as two-part or one-part systems cured by chemical activation or photo initiation.
Recommended Actions
- Conduct comprehensive physical property testing according to ISO 4049
- Perform biocompatibility testing per ISO 7405 or reference predicate data
- Prepare detailed chemical composition documentation
- Develop comprehensive labeling including all required physical properties
- Perform risk analysis addressing identified risks
- Prepare comparison to predicate device
- Consider if clinical studies are needed based on device novelty
- Document all test methods and results in summary report
- Prepare complete 510(k) submission including all required elements
- Ensure compliance with quality system requirements
Key Considerations
Clinical testing
- Clinical studies may be required for:
- Indications dissimilar from legally marketed devices
- Novel designs
- New technology
- Most devices considered non-significant risk under IDE regulations
Non-clinical testing
- Physical properties testing required including:
- Compressive strength
- Flexural strength
- Elastic modulus
- Depth of cure
- Surface hardness
- Radio-opacity
- Water sorption
- Working/setting time
Labelling
- Must include physical properties:
- Compressive strength
- Flexural strength
- Light intensity and wavelength for curing
- Working/setting times
- Depth of cure
Biocompatibility
- Testing required as per ISO 7405:1997(E)
- Previous data may be referenced if composition identical to predicate
Safety
- Risk analysis required to identify and address:
- Mechanical failure
- Toxicity
- Adverse tissue reactions
- Improper use
Other considerations
- Complete chemical composition required with CAS numbers
- Comparison to predicate device recommended
- Animal testing may be required with specific considerations for model selection
Relevant Guidances
- Premarket Notification Requirements for Dental Composite Resin Devices (Draft)
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
Related references and norms
- ISO 4049:2000(E): Dentistry - Polymer-based filling, restorative and luting materials
- ISO 7405:1997(E): Dentistry - Preclinical evaluation of biocompatibility of medical devices used in dentistry - Test methods for dental materials
Original guidance
- Premarket Notification Requirements for Dental Composite Resin Materials
- HTML
- Issue date: 2005-10-25
- Last changed date: 2020-03-19
- Status: FINAL
- Official FDA topics: Medical Devices, Premarket
- ReguVirta summary file ID: 4bcd9b182962d3d0f7559c3fa6a7c4d3
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