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.
What You Need to Know? 👇
What are the key physical properties required for dental composite resin 510(k) submissions?
FDA requires evaluation of compressive strength, flexural strength, elastic modulus, depth of cure, filler particle size distribution, surface hardness, radio-opacity, water sorption, solubility, working time, and setting time according to ISO 4049:2000(E) standards.
When are clinical studies required for dental composite resin devices?
Clinical studies may be required for devices with indications dissimilar from legally marketed devices (e.g., bone remineralization), novel polymer systems, or new technology like novel setting mechanisms or placement techniques.
What biocompatibility testing is recommended for dental composite resins?
FDA recommends biocompatibility testing per ISO 7405:1997(E) for dental materials. Alternatively, you may reference predicate devices or literature demonstrating biocompatibility for the same composition and tissue contact type.
Can I submit an Abbreviated 510(k) for dental composite resin devices?
Yes, FDA recommends Abbreviated 510(k) submissions as the least burdensome approach. Include a summary report describing how this guidance was used, test methods, and acceptance criteria addressing identified risks.
What labeling information must be included for dental composite resins?
Labeling must include compressive strength, flexural strength, light intensity and wavelength for curing, depth of cure, working time, curing time, setting time, and any other relevant properties enabling practitioners to determine device characteristics.
What devices are excluded from this dental composite resin guidance?
This guidance excludes resin tooth bonding agents, dental cements, coating materials for resin fillings, bracket adhesive resins, and temporary crown and bridge resins, which are intended for different uses.
What You Need to Do 👇
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 ID: 4bcd9b182962d3d0f7559c3fa6a7c4d3