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This is a draft guidance. Not for implementation.
What You Need to Know? 👇
What are the key biocompatibility endpoints required for dental composite resin devices?
Per ISO 7405, dental composite resins must address cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, subacute/subchronic toxicity, and genotoxicity as they are external communicating devices with permanent tissue contact.
Which product codes are covered under the new FDA draft guidance for dental composite resins?
The guidance covers product codes EBF (Tooth Shade Resin Material) under 21 CFR 872.3690 and EBC (Pit and Fissure Sealant and Conditioner) under 21 CFR 872.3765.
What physical and mechanical properties must be tested for dental composite resin 510(k) submissions?
Required tests include compressive strength (MPa), flexural strength (MPa), elastic modulus (GPa), surface hardness (KHN), water absorption (μg/mm³), and water solubility (μg/mm³) per ISO 4049 standards.
When is clinical testing required for dental composite resin devices in 510(k) submissions?
Clinical testing is generally unnecessary for most dental composite resins but may be required for devices making performance claims about longevity, tooth remineralization, reduced decay, or other enhanced clinical outcomes.
What shelf life testing approach does FDA recommend for dental composite resin devices?
FDA recommends accelerated aging per ASTM F1980 followed by real-time aged sample testing conducted in parallel with 510(k) review. Results should be documented in the design history file.
What material characterization information must be provided for dental composite resin devices?
Complete chemical composition including all polymers, monomers, initiators, curing agents, stabilizers, plasticizers, fillers, colorants, and additives must be quantified by percent mass totaling 100%, with CAS Registry Numbers when available.
What You Need to Do 👇
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