Premarket Notification Requirements for Dental Composite Resin Devices (DRAFT)
This guidance covers dental composite resin devices regulated under 21 CFR 872.3690 and 21 CFR 872.3765, specifically for tooth shade resin materials and pit/fissure sealants. It excludes resin restoratives for cementing, coating, fixation, and temporary restoration purposes.
This is a draft guidance. Not for implementation.
Recommended Actions
- Provide complete device description including chemical composition and accessories
- Conduct comprehensive non-clinical testing:
- Material characterization
- Physical/mechanical properties
- Curing parameters
- Radiopacity
- Perform biocompatibility evaluation addressing all required endpoints
- Conduct shelf life testing with both accelerated and real-time aging
- Prepare labeling with all required information for professional use
- Document predicate comparison demonstrating substantial equivalence
- Consider if clinical testing is needed based on device claims
- Evaluate if any proposed changes require a new 510(k)
- Ensure compliance with recognized standards and maintain documentation
- Consider pre-submission consultation for novel features or claims
Key Considerations
Clinical testing
- Generally unnecessary for most dental composite resin devices
- May be required for claims about device performance like longevity, tooth remineralization, reduced decay or other enhanced clinical outcomes
- Real-world data may be used to support labeling statements about enhanced clinical outcomes for already cleared devices
Non-clinical testing
- Material characterization with complete chemical composition
- Physical properties testing (compressive strength, flexural strength, elastic modulus, surface hardness)
- Water absorption and solubility testing
- For photoinitiated resins: light intensity, wavelength, curing times, depth of cure
- For self-curing resins: working and setting times
- Radiopacity testing
Labelling
- Must include adequate information for use by licensed practitioners
- Should specify: compressive/flexural strength, light intensity/wavelength for curing, depth of cure, curing times, working/setting times
- Must meet prescription device labeling requirements under 21 CFR 801.109
Biocompatibility
Testing required for:
- Cytotoxicity
- Sensitization
- Irritation
- Acute systemic toxicity
- Subacute/subchronic toxicity
- Genotoxicity
Safety
- Shelf life testing required to support expiration date
- Accelerated aging studies should be confirmed with real-time aged samples
Other considerations
- Complete device description required including principle of operation and chemical composition
- Predicate comparison needed showing similarities and differences
- Changes requiring new 510(k): Those affecting safety/effectiveness or major changes to intended use
Relevant Guidances
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Shelf Life and Stability Testing for Medical Devices
Related references and norms
- ISO 7405: Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
- ISO 4049: Dentistry — Polymer-based restorative materials
- ISO 6874: Dentistry — Polymer-based pit and fissure sealants
- ISO 9917-2: Dentistry – Water-based cements – Part 2: Resin-modified cements
- ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Original guidance
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