Premarket Notification Requirements for Over-The-Counter Denture Products and Repair Kits
This guidance provides recommendations for manufacturers of OTC denture cushions/pads, denture reliners, denture repair kits, and partially fabricated denture kits regarding the preparation of premarket notification (510(k)) submissions. It outlines the necessary information for evaluating substantial equivalence of these dental devices.
Recommended Actions
- Prepare detailed product description with comparison to predicate device
- Document complete chemical formulation with MSDS for all components
- Conduct physical and mechanical properties testing according to relevant standards
- Perform required biocompatibility testing if using new materials
- Develop compliant labeling with required warnings and instructions
- Prepare 510(k) summary or statement
- Include Truthful and Accurate Statement
- Complete Indications for Use form
- Compile all test results and documentation for submission
- Consider early consultation with FDA for new materials requiring extensive testing
Key Considerations
Non-clinical testing
- Physical and mechanical properties testing including:
- Color stability
- Hardness
- Linear shrinkage
- Peak temperature of polymerization
- Porosity
- Solubility
- Strength
- Water absorption
Labelling
- Must include clear warning statements as per 21 CFR Part 801.405
- For denture reliners, pads, and cushions: Warning about temporary use only
- For repair kits: Warning about emergency repairs only
- Must include adequate directions for use
- All promotional and advertising materials must be included in submission
Biocompatibility
- Required tests for new materials:
- In Vitro Cytotoxicity
- Ames Test for Mutagenicity
- Mucus Membrane Irritation
- Sensitization Test
- Carcinogenicity (if tumorigenic potential unknown)
Safety
- Complete material formulation must be provided
- Material Safety Data Sheet (MSDS) for each component required
- Chemical identity of all components must be specified
Other considerations
- Product description must include detailed comparison to predicate device
- Complete chemical formulation must total 100%
- Specific chemical names required (no proprietary names)
Relevant Guidances
- Regulatory Considerations for Microneedling Devices Used in Aesthetic Skin Treatments
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Premarket Notification Requirements for Dental Composite Resin Materials
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
Related references and norms
- ANSI/ADA Specification No. 12: Denture Base Polymers
- ANSI/ADA Specification No. 13: Denture Cold-Curing Repair Resins
- ANSI/ADA Specification No. 17: Denture Base Temporary Relining Resins
- ISO-10993-1: Biological Evaluation of Medical Devices
- ANSI/ADA Document No. 41: Recommended Standard Practices for Biological Evaluation of Dental Materials
Original guidance
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