A private-label (OEM) manufacturer produces clear aligners that you sell under your own brand. K Line is 100% B2B: we manage manufacturing, compliance, and logistics so you can focus on marketing, sales, and patient care. We operate as the engine behind your brand — not the name on the box.

White label products are generic and sold to multiple companies with minimal customization. Private label is a true OEM partnership: your aligners are produced exclusively for your brand, integrated into your workflow, and delivered with fully customized packaging and branding.

Becoming a medical device manufacturer requires ISO 13485, FDA registration, EU MDR compliance, and a complete Quality Management System — a process that takes years and significant investment. With K Line, you access an existing, fully certified global infrastructure from day one and convert heavy CapEx into predictable OpEx, allowing you to invest your capital into brand and growth instead of regulation and equipment.

After approval of your brand assets and packaging, most partners launch within 4–6 weeks. We guide you through onboarding, regulatory alignment, training, and logistics to ensure a fast and compliant start.