FDA 510 (k)

In the medical device manufacturing industry, it is a big step forward to achieve the FDA 510(k) approval. For Taglus it has been a significant moment of achievement to have been able to achieve this for our customer Illusion Aligners. As a manufacturer of innovative aligner and retainer sheets, we provide to various aligner makers around the globe thus, in turn, contributing to the continually growing global dentistry market. According to a report* by Fortune Business Insights, “The global clear aligner market size is projected to reach USD 10.04 billion by 2028”. As the report continues to say, “With the demand for teeth aesthetics rapidly rising, especially among teenagers, dental companies are focusing on developing new age clear aligners to cater to these evolving consumer trends”. At Taglus, we are putting our best efforts to step up together with this growing industry to take our place as major suppliers for dental aligner materials. With our internationally used clear aligner materials, we aim to continue to provide the highest quality for this growing market. Taglus Premium Sheets are a safe and ideal choice to manufacture the clear aligners by the thermoforming procedure according to the requirement of each patient, now more evident by the grant of FDA (US) 510(k) approval for Illusion Aligners. With continued efforts, Taglus Premium Sheets are now even better than before. It now absorbs more force before breakage, with its impact strength increased by 11.7%. Its flexural modulus of elasticity is reduced by 9.7%, making it more elastic and comfortable to wear. Its easy see-through lamination and easy peel-off technology also make this material a favorite for the dental labs to work with. Each of the Taglus Premium sheets is also marked with unique UDI DI numbers, making them traceable. The US FDA 510(k) approval has helped us prove to our customers the high standards of material that we provide in our commitment to serving them better. Source*- https://www.globenewswire.com/en/news-release/2021/05/06/2224268/0/en/Clear-Aligners-Market-Size-2021-Is-Projected-to-Reach-USD-10-04-Billion-by-2028-Exhibiting-a-CAGR-of-19-7.html

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