Technical Performance Testing for Dental Cements and Resin-Modified Materials
This guidance covers dental cements classified as Class II devices under specific product codes (EMA, KLE, DYH), including: - Water-based cements (powder/liquid acid-base cements) - Resin-modified cements - Dental composite resins that are combination products The devices are intended for temporary tooth filling, base cement for temporary filling, affixing dental devices (crowns, bridges, orthodontic brackets), or tooth protection and restoration retention.
What You Need to Know? 👇
What is the Safety and Performance Based Pathway for dental cements?
The Safety and Performance Based Pathway is an optional FDA framework allowing dental cement manufacturers to demonstrate substantial equivalence by meeting FDA-identified performance criteria rather than directly comparing to predicate devices, providing a less burdensome regulatory approach.
Which dental cements are covered under this FDA guidance?
The guidance covers Class II dental cements including dental cement (21 CFR 872.3275), resin tooth bonding agents (21 CFR 872.3200), and bracket adhesive resins (21 CFR 872.3750). It excludes acid etching gels, zinc oxide-eugenol cements, and denture adhesives.
What are the key performance criteria for dental cement adhesive bond strength?
Shear bond strength must range between 5-20 MPa depending on application (temporary vs permanent) and target surface material (dentin, enamel, ceramic, polymer, metal). Testing follows ISO 29022 methodology with rationale required if outside this range.
What biocompatibility testing is required for dental cements under this pathway?
Required endpoints include cytotoxicity, sensitization, oral mucosa irritation, acute systemic toxicity, subacute/subchronic toxicity, and genotoxicity. Devices are categorized as external communicating devices with prolonged/permanent tissue contact duration per ISO 10993-1.
How does film thickness testing apply to dental luting cements?
Luting cements must demonstrate maximum film thickness of 25 µm when tested according to FDA-recognized versions of ISO 9917-1 or ISO 9917-2. This requirement applies only to luting cements, not all dental cements covered by the guidance.
What documentation is needed for 510(k) submission using this pathway?
Submissions require Declaration of Conformity (DOC) for applicable tests, results summaries, test protocols where specified, and complete biocompatibility evaluation. FDA may request underlying data demonstrating compliance with performance criteria and testing methodology as necessary.
What You Need to Do 👇
Recommended Actions
- Determine if your device falls within the scope of this guidance
- Conduct all required non-clinical testing according to specified methodologies
- Perform complete biocompatibility evaluation as per FDA guidance
- Prepare test reports and Declarations of Conformity (DoC) for all applicable tests
- Consider submitting a Pre-Submission if additional testing beyond guidance requirements is needed
- Compile all test results summaries and supporting documentation for 510(k) submission
- Ensure all performance criteria are met before submission
- Document any deviations with proper justification
- If using identical materials as predicate device, prepare documentation for biocompatibility rationale
Key Considerations
Non-clinical testing
- Adhesive bond strength testing (5-20 MPa range)
- Ion release profile testing (if applicable)
- Film thickness testing for luting cements (max 25 µm)
- Net setting time testing (specific ranges based on application)
- Compressive strength testing for powder/liquid acid-base cements (≥50 MPa)
- Acid erosion testing for powder/liquid acid-base cements
- Working time testing for resin-modified cements (≥1.5 minutes)
- Flexural strength testing for resin-modified cements (≥10 MPa)
- Water sorption testing (≤40 μg/mm³)
- Water solubility testing (≤7.5 μg/mm³)
Biocompatibility
- Cytotoxicity
- Sensitization
- Oral Mucosa Irritation
- Acute Systemic Toxicity (Oral Application)
- Subacute/Subchronic Toxicity (Oral Application)
- Genotoxicity
Relevant Guidances 🔗
- Performance Testing and Safety Requirements for Single-Use Cutaneous Recording Electrodes
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Safety and Performance Based Pathway for 510k Substantial Equivalence Demonstration
- Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
Related references and norms 📂
- ISO 9917-1: Dentistry – Water-based cements – Part 1: Powder/liquid acid-base cements
- ISO 9917-2: Dentistry – Water-based cements Part 2: Resin-modified cements
- ISO 29022: Dentistry-Adhesion – Notched-edge shear bond strength test
- ISO 4049: Dentistry – Polymer-based restorative materials
- ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- ISO 7405: Dentistry –Evaluation of biocompatibility of medical devices used in dentistry