Tests Required for Dental Aligners — FDA 510(k)

Submitting a sequential dental aligner (clear aligner) notification for 510(k) clearance requires the submission of various tests and information to the FDA. Some of the tests that may be required for a sequential dental aligner (clear aligner) include:

Dental Aligner 510K – Test Requirements.

1. Biocompatibility Testing:
   • Primary Skin Irritation ISO – 10993
   • Dermal Sensitization ISO – 10993
   • In vitro cytotoxicity ISO – 10993
   • Acute systemic toxicity – ISO10993
2. Non-Clinical Testing:
   • Density – ASTM D1505
   • Water absorption – ASTM D570
   • Tensile Strength – ASTM D882
   • Elongation at Break – ASTM D882
   • E-modulus – ASTM D882
3. Shelf Life Testing

It’s essential to note that the required tests can vary depending on the specific product’s characteristics and intended use, so it is crucial to consult with the FDA Consultant to ensure that all necessary testing is conducted and submitted for 510(k) clearance.

LMG Provides assistance to dental aligner manufacturers in FDA registration, 510k clearance, device listing, and US FDA Agent requirements. Our experienced consultants can help you to comply with FDA requirements. Our expertise includes

• Prepare 510k notification
• Submission of 510k notification
• FDA Agent service for 510k submission
• Guidance in test requirements
• Register your dental establishment with FDA
• List your dental aligner with FDA.