Clear Aligner Manufacturing Partner Vetting Checklist

Certifications & Regulatory Status

See our step-by-step FDA & ISO verification guide for exactly how to check these.

Ask for the specific FDA 510(k) number for the aligner material used, and verify it in the FDA database. Ask for a current ISO 13485 certificate and its expiration date. If shipping into the EU, UK, or Australia, confirm CE/EU MDR, MHRA, or TGA status as applicable.

Quality & Traceability

Ask how materials and production steps are traced back through the manufacturing chain. Ask whether a documented CAPA (corrective and preventive action) process exists for defects.

Clinical Team

Ask how many years of clinical experience the treatment planning team carries. Confirm which malocclusion classes and case complexities the team can plan for. Ask whether you retain sign-off on the treatment plan before production begins.

Commercial Terms

Ask about the minimum order quantity, if any. Get a clear, itemized breakdown of per-case pricing, including planning fees and shipping. Ask for a typical treatment plan turnaround time in business days. Confirm whether treatment planning and manufacturing can be used independently of each other.

Logistics & Branding

Confirm which countries or regions the manufacturer ships to. If private or white labeling, confirm what branding and packaging customization is actually available.

See How AlignerHub Answers Every Item

FDA 510(k)-cleared material, ISO 13485-certified partners, an ex-Invisalign and ex-ClearCorrect clinical team, no minimum order quantity, and treatment planning available on its own.

See Our Answers in the FAQ