Top manufacturer of OEM clear aligners in Europe recently garners United States Food and Drug Administration registration.
K Line Europe, a top manufacturer of OEM clear aligners in Europe, has recently received United States Food and Drug Administration (FDA) registration to offer its top-selling K Clear Aligners in the United States.
The K Line delivers a best-in-class refinement rate of only 15.8%, according to the manufacturer. The low refinement rate suggests that practitioners will deliver more predictable case outcomes, more satisfied patients, and greater productivity. When clinicians are spending less time reworking existing cases than what is required due to the higher refinement rates of competitors, they can work more efficiently.
K Line Europe’s process is designed to achieve its 15.8% rate by having every case created by an expert team of orthodontists and dentists, not an artificial intelligence (AI) software program, or lab tech. K Line currently manufactures 7,000 aligners daily to exact specifications at its new, state-of-the-art facility in Germany.
The clear aligners are made from K Line’s K Flex multi-layered material. This material is formulated to provide increased patient comfort, durability, and predictable tooth movement.
The company’s platform works with all 3D intraoral scanners creating a universal STL file. Additionally, K Line’s submission portal is free of charge with no monthly fees. All the aligners are manufactured in 3 to 5 days after case submission, then overnighted to the company’s newly opened distribution center in Florida. The cases are then boxed up at the distribution center, and shipped out to the clinics free of charge, and this entire process takes 14-16 days on average, according to the company.
K Line products will soon be available from most full-service dental dealers in the US. K Line also offers private label opportunities to dental dealers, groups, and dental service organizations (DSOs). For additional information, those interested can contact their authorized K Line dealer or visit the company’s website at www.k-lineus.com.