
Smile Find Plastic 3 Layer TPU Vacuum Forming TPU Clear Orthodontic Sheets. 510K & CE Compliance: Materials certified for global markets, compatible with major pressure and vacuum machines. High Stress Retention: Ensures effective aligner therapy with reliable performance. Non-Toxic & Food Safe: Raw materials are non-toxic, tasteless, and safe for oral use. GMP Cleanroom Production: Manufactured in a 100,000-class GMP cleanroom with a 0.2% defect rate. ISO13485 & ISO22716 Certified: Adheres to international quality standards for medical devices. 18 Years Industry Experience: Serving 80+ top brands and exporting to 100+ countries in orthodontics. Comprehensive Testing: Four experienced technicians conduct stability, microbiological, and efficacy tests.