Testing and Labeling Requirements for Titanium Alloy Dental Implants and Abutments
This guidance covers root-form endosseous dental implants and endosseous dental implant abutments, which are Class II devices regulated under 21 CFR 872.3640 and 21 CFR 872.3630. The devices are intended for surgical placement in upper/lower jaw bones to support prosthetic devices and restore chewing function. The guidance specifically addresses devices made from titanium alloys conforming to ASTM F67, F136, or F1295 standards.
What You Need to Know? 👇
What is the Safety and Performance Based Pathway for dental implants?
The Safety and Performance Based Pathway is an optional FDA route where manufacturers can demonstrate substantial equivalence by meeting FDA-identified performance criteria instead of directly comparing their device to a predicate device, making the approval process less burdensome.
Which materials are acceptable for endosseous dental implants under this guidance?
Only titanium materials conforming to ASTM F67 (unalloyed titanium), ASTM F136 (Ti-6Al-4V ELI), or ASTM F1295 (Ti-6Al-7Nb) standards are acceptable. The devices must be manufactured solely from one of these materials.
What are the maximum endured load requirements for dynamic loading tests?
Requirements vary by implant diameter: 3.0-3.3mm requires 150N, 3.4-3.5mm requires 170N, 3.6mm requires 180N, and greater than 3.6mm requires 200N. Testing must be performed on the worst-case construct configuration.
Are additively manufactured dental implants covered by this guidance?
No, additively manufactured devices are explicitly excluded from the scope of this guidance. The pathway only applies to conventionally manufactured endosseous dental implants and abutments meeting the specified design characteristics.
What biocompatibility testing is required for dental implants?
All endpoints from FDA’s ISO 10993-1 guidance must be assessed, including cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, sub-acute/sub-chronic toxicity, genotoxicity, implantation, chronic toxicity, and carcinogenicity for prolonged/permanent contact devices.
When is reverse engineering analysis required for compatibility demonstration?
Reverse engineering analysis is recommended when you cannot establish implant-to-abutment compatibility based solely on descriptive information, such as when manufacturing tolerances for platform size and shape of another manufacturer’s device are unavailable.
What You Need to Do 👇
Recommended Actions
- Determine if device falls within scope of guidance based on materials and design characteristics
- Prepare detailed engineering drawings showing all required device characteristics
- Conduct dynamic loading testing if applicable (angled abutments)
- Perform surface cleanliness analysis for blasted/roughened implants
- Complete sterilization validation and packaging testing as applicable
- Conduct appropriate biocompatibility testing or prepare rationale for waiving tests
- Develop labeling with required warnings based on maximum endured load
- Prepare reverse engineering analysis if needed for compatibility claims
- Document test results in appropriate format with sample size justifications
- Consider Pre-Submission meeting if additional testing beyond guidance scope is needed
Key Considerations
Non-clinical testing
- Dynamic Loading Test required for systems with angled abutments following ISO 14801
- Maximum endured load requirements based on major thread diameter
- Surface Cleanliness Analysis using SEM and EDS for blasted/roughened implants
- No particles or residual chemicals should be present on the surface
Human Factors
- Usability evaluation for aseptic presentation required for single-layered sterile barrier systems
Labelling
- Specific warnings required based on maximum endured load values
- Instructions for unpackaging process for single-layered sterile barrier systems
- Validated sterilization cycle instructions for non-sterile devices
Biocompatibility
- Assessment required for cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, sub-chronic toxicity, genotoxicity, implantation, chronic toxicity, and carcinogenicity
- Testing can be reduced if using identical materials and processes as predicate device
- Basic biocompatibility testing (cytotoxicity, sensitization, irritation) required even for standard materials
Safety
- Sterilization validation to SAL 10-6 required for sterile devices
- Sterile barrier system validation required
- Endotoxin testing required for sterile devices
Other considerations
- Reverse engineering analysis may be required to establish implant-to-abutment compatibility
- Multiple manufacturing lots should be tested for surface analysis
- Sample size justification required for testing
Relevant Guidances 🔗
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Submission Requirements for Terminally Sterilized Medical Devices
- Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
Related references and norms 📂
- ISO 14801: Dentistry - Implants - Dynamic loading test for endosseous dental implants
- ISO 17665-1: Sterilization of health care products – Moist heat
- ISO 11135: Sterilization of health care products – Ethylene oxide
- ISO 11137-1: Sterilization of health care products —Radiation
- ISO 20857: Sterilization of health care products — Dry heat
- ISO 11607-1: Packaging for terminally sterilized medical devices – Part 1
- ISO 11607-2: Packaging for terminally sterilized medical devices – Part 2
- ASTM F67: Standard Specification for Unalloyed Titanium
- ASTM F136: Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI
- ASTM F1295: Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy