Placing an orthodontic device on the US market is a documentation problem before it is a manufacturing one. Every credential below is issued to you before your first case — not promised and then chased.
510(k) · K241137
FDA clearance
Cleared by the U.S. Food and Drug Administration under product code NXC in August 2024. Substantially equivalent to legally marketed devices, so US dentists partner with reduced liability and full state-board confidence.
ISO 13485
Quality management system
Full QMS covering design control, supplier qualification, process validation, traceability and CAPA. Batch records retained per case, certificate available under NDA.
ISO 10993
Biocompatibility tested
Every medical-grade, BPA-free thermoplastic is biocompatibility tested before clinical use, so what sits in your patient mouth meets US safety expectations.
Traceability
Serialized and laser marked
Every aligner is serialized and traceable via laser marking, giving your practice a full audit trail from material intake to the tray on the chair.
Global standards
Six certifications
Beyond the FDA we hold ISO 13485, CE, EU MDR, UK MHRA and Australia TGA — one of the most comprehensively certified aligner manufacturers you can put your brand on.
Data handling
HIPAA-conscious workflow
Intraoral scans and case records move over encrypted channels with defined retention. Your practice stays the custodian of patient data; we act strictly as the manufacturing processor.
FDA 510(k) summary, ISO 13485 certificate and material safety data sheets supplied on request before your first case.