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.
What You Need to Know? 👇
What are the key biocompatibility testing requirements for OTC denture products?
The minimum required tests include in vitro cytotoxicity, Ames test for mutagenicity, mucus membrane irritation (hamster’s pouch), sensitization test in guinea pigs, and carcinogenicity testing if tumorigenic potential hasn’t been previously documented.
Are OTC denture repair kits still subject to 510(k) premarket notification requirements?
No, as of January 31, 2018, OTC denture repair kits (Product Code EBO, 21 CFR 872.3570) are exempt from premarket notification (510(k)) requirements according to the Federal Register of March 14, 2018.
What chemical information must be disclosed in a 510(k) submission for denture products?
Complete material formulation with individual components by percentage totaling 100%, specific chemical names (not trade names), function of each component, CAS numbers, material safety data sheets, chemical structure diagrams, and all pigments/colorants used.
What are the mandatory warning statements for OTC denture cushions and reliners?
“Warning—For temporary use only. Long term use of this product may lead to faster bone loss, continuing irritation, sores, and tumors. For Use Only Until A Dentist Can Be Seen.”
Which physical and mechanical properties must be tested for denture base materials?
Color stability, hardness (Knoop, HK), linear shrinkage (%), peak polymerization temperature (°C), porosity, solubility (mg/cm²), strength (transverse deflection, mm), and water absorption (mg/cm²) must be evaluated and compared to predicate materials.
What is the difference between Class I and Class III OTC denture cushions or pads?
Class I devices are made of wax-impregnated cotton cloth intended for one day’s use and disposal. Class III devices are made of other materials or not intended for single-day disposal.
What You Need to Do 👇
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