Achieving FDA 510(k) clearance is one of the most important milestones for any orthodontic device entering the US market. This clearance confirms that Clear Moves Aligners are substantially equivalent to legally marketed devices and meet the FDA's standards for biocompatibility, material safety, and clinical performance.
For US dentists and orthodontists, partnering with an FDA-cleared manufacturer means reduced liability, higher patient confidence, and compliance with state dental board requirements. Our aligners are manufactured using medical-grade, BPA-free thermoplastic materials that are rigorously tested at every stage of production.
Beyond the FDA, Clear Moves Aligners holds certifications from global regulatory bodies — including ISO 13485, CE marking, EU MDR, UK MHRA, and Australia's TGA — making us one of the most comprehensively certified aligner manufacturers in the world.
Biocompatibility Tested
All materials undergo ISO 10993 biocompatibility testing before clinical use.
Full Traceability
Every aligner is serialized and traceable via laser marking per FDA requirements.
6 Global Certifications
FDA, ISO 13485, CE, EU MDR, MHRA, and TGA for worldwide compliance.